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Bisphosphonate
Alendronate + Teriparatide for Osteoporosis
Phase 4
Recruiting
Led By hartmut h Mallluche, md
Research Sponsored by Hartmut Malluche, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
45 years old and older
Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will help create a new, better way to treat osteoporosis that accounts for the different ways it can develop in people.
Who is the study for?
This trial is for women aged 45 and older with diagnosed osteoporosis (bone density score ≤ -2.5), who haven't used bone drugs before, regardless of menopause status or diabetes presence. Exclusions include chronic substance abuse, certain systemic illnesses affecting bones, pregnancy, recent participation in other drug trials, planned surgeries within a year, inability to sit/stand for 30 minutes, and plans to move away soon.Check my eligibility
What is being tested?
The study tests Alendronate versus Teriparatide as treatments for osteoporosis in postmenopausal women. It aims to tailor treatment based on non-invasive determination of age-related bone loss without needing biopsies—potentially revolutionizing how this common condition is managed.See study design
What are the potential side effects?
Alendronate may cause digestive issues like heartburn or ulcers; rarely jaw problems or unusual thigh bone fractures. Teriparatide can lead to increased calcium levels in the blood, leg cramps or dizziness; infrequently it might be linked with an increased risk of bone cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 45 years old or older.
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I have been diagnosed with osteoporosis based on a DXA scan.
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I have diabetes.
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I am a woman who may be before, during, or after menopause.
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I have been diagnosed with osteoporosis based on a bone density scan.
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I have not taken any bone-strengthening drugs.
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I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of serum osteocalcin levels to predict bone turnover
Mineral Bone Density of the lumbar spine
Trial Design
3Treatment groups
Active Control
Group I: Group 3 Normal-High TurnoverActive Control1 Intervention
Standard of Care Treatment with Alendronate (antiresorber) For 1 Year
Group II: Group 1 Low TurnoverActive Control1 Intervention
Teriparatide (anabolic) For 1 Year
Group III: Group 2 Low TurnoverActive Control1 Intervention
Standard of Care - Control:
Treated with Alendronate (antiresorber) For 1 Year
Find a Location
Who is running the clinical trial?
Hartmut Malluche, MDLead Sponsor
3 Previous Clinical Trials
645 Total Patients Enrolled
1 Trials studying Osteoporosis
40 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,003 Total Patients Enrolled
22 Trials studying Osteoporosis
12,208 Patients Enrolled for Osteoporosis
hartmut h Mallluche, mdPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bone conditions not related to aging or menopause.I cannot sit or stand up straight for 30 minutes.I plan to have oral surgery in the next year.I am 45 years old or older.I have had cancer before, but not skin cancer.I have been diagnosed with osteoporosis based on a DXA scan.I am currently taking medication to prevent blood clots.You have a long-term problem with alcohol or drug addiction.I have diabetes.Your vitamin D level is lower than the normal range (below 20ng/mL).I have no illnesses affecting my bones, except possibly diabetes.I do not have severe heart, lung, or other infections that could limit my participation.I have had radiation therapy on my bones and might receive Forteo.I chose not to continue in the study after learning my bone density score.I am a woman who may be before, during, or after menopause.I have been diagnosed with osteoporosis based on a bone density scan.I have a condition that makes it hard for food to move from my mouth to my stomach.You have normal levels of vitamin D in your body.I have not taken any bone-strengthening drugs.I am 40 years old or older.I am taking medication for bone strengthening or growth.I am allergic to demeclocycline or tetracycline antibiotics.I am female.It seems like the criterion "Absence of all" might be incomplete or unclear. Can you provide more context or details so I can better understand and rewrite this criterion for you?
Research Study Groups:
This trial has the following groups:- Group 1: Group 3 Normal-High Turnover
- Group 2: Group 1 Low Turnover
- Group 3: Group 2 Low Turnover
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other analyses that have focused on Group 3 Normal-High Turnover?
"Currently, 22 clinical trials are live for Group 3 Normal-High Turnover. Of these studies, two have reached Phase 3 status. Most of the participating sites for this group are located in Douliu, Yunlin County; yet there is a total of 54 operating locations worldwide."
Answered by AI
Is this research program open for enrollment?
"Affirmative, the information on clinicaltrials.gov depicts that this examination is actively searching for participants. This medical trial was initially posted on March 21st 2022 and had its latest amendment made on May 16th 2022. It requires 60 people to be recruited at a single location."
Answered by AI
Are there any risks associated with Group 3 Normal-High Turnover for patients?
"Our team at Power rate Group 3 Normal-High Turnover as a level 3 on the safety scale, which is to be expected since this treatment has passed Phase 4 trials and been approved."
Answered by AI
What is Group 3 Normal-High Turnover commonly utilized to treat?
"Group 3 Normal-High Turnover is an effective intervention for treating osteoporosis, postmenopausal women and patients with Paget's Disease."
Answered by AI
How many individuals are enrolled as participants in this trial?
"Affirmative. The particulars of this medical trial, posted on March 21st 2022, are accessible via clinicaltrials.gov and suggest that 60 participants are being sought from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I would like more support and information as I take these very expensive medications, such as monitoring of bine growth indicators.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of Kentucky: < 48 hours
Average response time
- < 2 Days
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