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75 Osteoporosis Trials near Miami, FL
Power is an online platform that helps thousands of Osteoporosis patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerZoledronic Acid for Parkinson's Disease
Miami, Florida
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 2650 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:60+
Key Eligibility Criteria
Disqualifiers:Hip Fracture, Non-ambulatory, Kidney Dialysis, Others
Must Not Be Taking:Bisphosphonates, SERMs, Denosumab
2650 Participants Needed
Oral Contraceptive for Birth Control
Miami, Florida
This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:13 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Amenorrhea, Thromboembolism, Others
Must Not Be Taking:Barbiturates, Anticonvulsants, Rifampin, Others
1009 Participants Needed
Denosumab for Osteoporosis
Hialeah, Florida
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 90
Sex:Female
Key Eligibility Criteria
Disqualifiers:Fractures, Bone Diseases, Malignancy, Others
Must Not Be Taking:Bisphosphonates, HRT, Glucocorticoids, Others
392 Participants Needed
SCF Supplementation for Bone Health in Adolescents
Miami, Florida
The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF) supplementation for 1 year on bone metabolism in growing adolescents compared to controls. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 10-13 years, equally randomly assigned to one of four intervention groups: SCF (12 g/d), SCF + calcium (12 g/d of SCF + 600 mg/d of elemental calcium), placebo (0 g/d of SCF or of calcium), and placebo + calcium (0 g/d of SCF + 600 mg/d of elemental calcium); all administered twice a day. Bone mass will be assessed at baseline at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:9 - 14
Key Eligibility Criteria
Disqualifiers:Chronic Illness, Others
Must Not Be Taking:Calcium, Vitamin D
240 Participants Needed
AGA2118 for Osteoporosis
Gainesville, Georgia
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 80
Sex:Female
Key Eligibility Criteria
Disqualifiers:Fractures, Vitamin D Deficiency, Cancer, Others
Must Not Be Taking:Bone Metabolism Agents
350 Participants Needed
Nexel Total Elbow Replacement for Elbow Osteoarthritis
Charlotte, North Carolina
This trial aims to confirm the safety and effectiveness of the Zimmer Nexel Total Elbow in patients needing their first or a revised elbow replacement. The device replaces damaged parts of the elbow to help reduce pain and improve function. The Zimmer Nexel Total Elbow is used to replace damaged parts of the elbow, primarily in patients with severe elbow pain and joint destruction.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Infection, Paralysis, Hand Dysfunction, Others
134 Participants Needed
Denosumab Switch for Osteoporosis
Birmingham, Alabama
Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Unstable Medical Condition, Hyperthyroidism, Hypothyroidism, Others
Must Be Taking:Glucocorticoids
45 Participants Needed
Bone Graft with rhPDGF vs. Saline for Dental Implants
Birmingham, Alabama
This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Smokers, Systemic Pathologies, Poor Compliance, Others
44 Participants Needed
New Approach vs Standard Care for Broken Bones Due to Osteoporosis
Birmingham, Alabama
RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:CKD Stage 4, Paget's, Myeloma, Others
Must Not Be Taking:Bisphosphonates, Denosumab, Romozosumab, Others
2634 Participants Needed
Resistance Exercise for Osteoporosis
Birmingham, Alabama
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:55 - 70
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypertension, Osteoporosis, Fracture, Cancer, Others
Must Not Be Taking:Osteoporosis Drugs
44 Participants Needed
Risedronate for Bone Loss After Bariatric Surgery
Winston-Salem, North Carolina
The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy.
Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:30+
Key Eligibility Criteria
Disqualifiers:Weight > 450 Lbs, Allergies, Others
Must Not Be Taking:Growth Hormones, Oral Steroids
200 Participants Needed
Alendronate + Exercise for Osteoporosis
Winston-Salem, North Carolina
The purpose of this research is to identify strategies that minimize bone loss that occurs when older adults lose weight. Participation in this research will involve up to nine assessment visits and last up to two years.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:60+
Key Eligibility Criteria
Disqualifiers:Osteoporosis, Uncontrolled Diabetes, Cancer, Others
Must Not Be Taking:Oral Steroids, Insulin, Biotin, Others
900 Participants Needed
Donepezil for Alzheimer's Effects on Bone Metabolism
Durham, North Carolina
People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality.
Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50+
Key Eligibility Criteria
Disqualifiers:Osteoporosis, Hip Fracture, Parkinson's, Others
Must Not Be Taking:Acetylcholinesterase Inhibitors, Osteoporosis Meds
45 Participants Needed
Injury Prevention Care Models for Osteoporosis
Durham, North Carolina
The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.
The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.
The main questions this study aims to answer are:
* Which of the three models is more effective in preventing falls with fractures?
* What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.
* What are the differences in osteoporosis treatment and medication burden?
The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.
42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.
This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Non-osteoporotic Fracture, Hospice, Others
3780 Participants Needed
Screening Models for Osteoporosis in Male Veterans
Durham, North Carolina
Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
39 Participants Needed
Oxytocin Nasal Spray for Autism
Charlottesville, Virginia
This trial tests if giving oxytocin through a nasal spray can improve bone health in children with autism. Children with autism often have weaker bones and lower levels of oxytocin. The study aims to see if oxytocin can help make their bones stronger. Oxytocin has been investigated for its potential to treat social deficits in autism spectrum disorders, with various studies exploring its effects on social behavior and brain function.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 18
Key Eligibility Criteria
Disqualifiers:Fragile X, Tuberous Sclerosis, Others
Must Not Be Taking:Bone Medications
96 Participants Needed
Teriparatide vs Alendronate for Osteoporosis
Lexington, Kentucky
Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.
Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 4
Age:45+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Oral Surgery, Alcoholism, Cancer, Others
Must Not Be Taking:Blood Thinners
40 Participants Needed
Alendronate + Teriparatide for Osteoporosis
Lexington, Kentucky
Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:40+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Oral Surgery, Cancer, Others
Must Not Be Taking:Anticoagulants, Anabolic Drugs
60 Participants Needed
Ultrasound Therapy for Osteoarthritis
Galveston, Texas
The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40+
Key Eligibility Criteria
Disqualifiers:Arthritis, Surgery, Pregnancy, Others
Must Not Be Taking:Systemic Corticosteroids
10 Participants Needed
Bone Health Referral for Joint Replacement Surgery
Columbia, Maryland
The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is:
1) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral.
Researchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Prior Osteoporosis Diagnosis, Treatment
2000 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
OPTIONS Program for Osteoporosis
Baltimore, Maryland
Osteoporosis is a disease that weakens bones so the bones may break easily. The risk for osteoporosis increases with age in both women and men. Osteoporosis affects 10 million older adults in the US. Osteoporosis is a common cause of broken bones in the hips and legs. Broken bones can lead to disability, nursing home placement, and death. Because of the dire consequences, a broken hip or leg is one of the most dreaded injuries for older adults. Many studies confirm that a simple regimen of exercise, healthy diet and bone-strengthening medications can improve overall recovery after a broken hip or leg. This regimen can prevent a person from becoming disabled, having future fractures, and even prevent death.
Many older adults have surgery in a hospital after breaking a hip or leg. Then older adults go to a skilled nursing facility (SNF) for rehabilitation. Care in SNFs varies greatly. Some patients do not receive the regimen that the investigators know is most beneficial to improve bone health and recovery. Even patients who get exercise, healthy diet, and bone-strengthening medication in the SNF, may not continue with the regimen once patients go home. Therefore, the investigators want to implement and test OsteoPorotic fracTure preventION System (OPTIONS). OPTIONS is a program that will integrate the regimen into the care that is provided in SNFs and after discharge to the community. OPTONS will provide information about exercise, diet, and bone-strengthening medication. OPTIONS will provide doctors, clinical staff, patients, and care partners with the information these stakeholders need to carry out the best-practice regimen.
The investigators are partnering with PointClickCare, a large cloud-based healthcare software provider, with SNFs and community care sites across the US. The investigators will include 32 SNFs from different US areas. The investigators will flip a coin to assign SNFs to the intervention (OPTIONS) or the control arm (enhanced usual care) of the study. Enhanced usual care is the care that is typically provided in SNFs after a fracture and adding information about a publicly available fall prevention toolkit. The investigators are using an "implementation science" approach that requires the investigators to get input from the OPTIONS study's vast stakeholder community throughout the study. The OPTIONS study's stakeholders include patients, care partners, clinicians, and professional organizations.
The research question is, can using OPTIONS in SNFs and in the community after discharge improve physical function and quality of life in older people in the year after a hip or leg fracture? The investigators are measuring patient-reported outcomes. The investigators will include 1553 patients across the 32 facilities. The investigators have selected outcomes that are important to patients. Specifically, the investigators are measuring patient-reported function and quality of life. The investigators are also measuring patient-reported falls and fractures. The investigators will track the number of patients who die during the study. This study's hypothesis is that patients who receive OPTIONS will report better physical function (i.e., can walk and take better care of themselves) than those who receive enhanced usual care. The investigators also hypothesize that patients that receive OPTIONS will report a better quality of life than those who receive enhanced usual care.
This study will provide sound data about the effectiveness of OPTIONS. OPTIONS could then be spread to other SNFs and community-based programs. This would ensure that all older people receive the right care after a hip or leg fracture.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Non-English/Spanish, No Phone, Hospice, Severe Cognitive Impairment
1553 Participants Needed
Estrogen Supplementation for Cystic Fibrosis
Baltimore, Maryland
This trial studies how estrogen skin patches affect bone health in young women with cystic fibrosis. Participants will use the patches regularly and undergo various health assessments. The goal is to see if this treatment can improve their bone health and quality of life. Estrogen replacement is recommended for female patients with CF-related bone disease to restore bone mineral density.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:0 - 100
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Transplant, Clot Risk, Others
Must Not Be Taking:Anti-osteoporosis, Systemic Estrogen, Glucocorticoids
75 Participants Needed
Romosozumab + Zoledronic Acid for Osteoporosis
Pittsburgh, Pennsylvania
The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:65+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Recent CVD, Renal Insufficiency, Others
Must Not Be Taking:Bisphosphonates, Denosumab, Teriparatide, Romosozumab
200 Participants Needed
Romosozumab for Osteoporosis
Pittsburgh, Pennsylvania
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are:
* Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery?
* Does romosozumab increase muscle mass and help patients recover better from surgery?
Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will:
* Be randomly assigned to receive romosozumab or alendronate
* Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study
* Attend five study visits over about 12 months
* Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:65+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Male, Severe Renal Impairment, Others
Must Not Be Taking:Osteoporosis Medications, Anabolic Agents
36 Participants Needed
Osteoporosis Medications for Muscle Health in Osteoporosis
Pittsburgh, Pennsylvania
This trial is studying how medications for weak bones might also help improve muscle health in older adults with both weak bones and muscles. Researchers believe these medications could benefit muscle strength and function by affecting the way bones and muscles work together.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:65+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Liver Disease, Men, Others
Must Be Taking:Osteoporosis Medications
20 Participants Needed
Potassium Citrate for Kidney Disease
Pittsburgh, Pennsylvania
The goal of this clinical trial is to test whether potassium citrate improves skeletal health in adults and children with chronic kidney disease. The main questions it aims to answer are:
* To evaluate effects of potassium citrate treatment on bone quality and strength.
* To evaluate mechanism(s) underlying the effects of potassium citrate on skeletal health.
Participants will be asked to:
* provide blood, urine and answer questions about health and diet three times during an 8 months period
* undergo advanced bone imaging with high resolution-peripheral quantitative CT scan twice during 8 months
* take study pills for 4-6 weeks at the beginning of the study to ensure safety
* take either potassium citrate or placebo for 6 months during the blinded portion of the study
As part of the study, there will be a run-in period followed by the placebo-controlled randomized clinical trial. Researchers will compare the bone imaging between the potassium citrate and the placebo groups at the end of the study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:5 - 100
Key Eligibility Criteria
Disqualifiers:Hyperkalemia, Acid-base Imbalance, Others
Must Not Be Taking:Bisphosphonates, Denosumab, Others
103 Participants Needed
Abaloparatide + Denosumab for Osteoporosis
Broomall, Pennsylvania
This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at 18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months. Secondary outcomes will also include within group changes from baseline for each of these variables. Bone turnover markers will also be measured to demonstrate that PINP levels will increase with administration of abaloparatide even in the setting of ongoing denosumab, while CTX levels will remain low.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:45+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Renal Stones, Cancer, Hypercalcemia, Others
Must Be Taking:Denosumab
70 Participants Needed
Osteoporosis Medication for Muscle Health in Older Adults
Pittsburgh, Pennsylvania
Our goal is to demonstrate efficacy of the novel agent Denosumab to improve or preserve muscle health, strength, mobility and function in frail older adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:65+
Key Eligibility Criteria
Disqualifiers:Subacute Illnesses, Hypocalcemia, Glucocorticoids, Others
Must Not Be Taking:Bisphosphonates, Denosumab, Teriparatide, Others
155 Participants Needed
Lutein, Zeaxanthin, and Fish Oil for Cognitive Functioning
College Station, Texas
The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults.
The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months?
Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation.
Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density.
Participants will be asked to take either a LZF supplement or placebo daily for 6 months.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Pregnancy, Vegan, Autoimmune Disorders, Others
Must Not Be Taking:Neuroactive Medications
80 Participants Needed
Dried Plums for Osteoporosis
University Park, Pennsylvania
Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. However, it is unknown in what quantity dried plums need to be consumed to be of benefit and through what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal women. The investigators also seek to evaluate the mechanisms underlying the effects of dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated metabolites in the urine of postmenopausal women taking different doses of dietary dried plums. The investigators aim to further investigate the mechanisms of dried plum action on bone by measuring markers of bone metabolism in response to dried plum consumption.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:55 - 75
Sex:Female
Key Eligibility Criteria
Disqualifiers:Vitamin D Deficiency, Fractures, Thyroid Issues, Others
Must Not Be Taking:Bisphosphonates, Denosumab, Estrogen, Others
322 Participants Needed
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Frequently Asked Questions
How much do Osteoporosis clinical trials in Miami, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Osteoporosis clinical trials in Miami, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Osteoporosis trials in Miami, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Miami, FL for Osteoporosis is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Miami, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Osteoporosis medical study in Miami, FL?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Osteoporosis clinical trials in Miami, FL?
Most recently, we added OPTIONS Program for Osteoporosis, Resistance Exercise for Osteoporosis and Romosozumab for Osteoporosis to the Power online platform.
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