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Bone Anabolic Drug
Combination Therapy for Osteoporosis in Men (Osteo-Men Trial)
Phase 4
Recruiting
Led By Dolores M. Shoback, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DXA BMD T-score < or = -2.0 at either lumbar spine (LS), femoral neck (FN) or total hip (TH) sites; or DXA BMD T-score < or = -1.5 with at least one additional important clinical risk factor for osteoporotic fracture
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Osteo-Men Trial Summary
This trial will test a new combination therapy for osteoporosis in men, based on findings in mice. The therapy includes the use of a bone anabolic drug (TPTD) and a calcimimetic drug (NPS-R568). This study will help to understand whether this new combination therapy is effective in men.
Who is the study for?
Men with osteoporosis can join this trial if they have a low bone mass score at certain sites in their body or additional risk factors for fractures. They must not have other metabolic bone diseases, severe heart issues, very high or low vitamin D levels, poorly controlled diabetes, recent cancer (except some skin cancers), and should not be on certain medications like steroids or drugs affecting calcium levels.Check my eligibility
What is being tested?
The study is testing whether a combination of two drugs—Teriparatide (TPTD) and Cinacalcet—is more effective than TPTD alone in increasing bone density and strength in men with osteoporosis. Participants will receive either the drug combo or TPTD with a placebo for 11 months to compare effects on spine and hip bone density as well as blood markers of bone metabolism.See study design
What are the potential side effects?
Possible side effects include nausea, dizziness due to changes in calcium levels; rare leg cramps or muscle spasms; injection site reactions from Teriparatide; and potential allergic reactions. Long-term use may affect bones differently but specific risks will be monitored closely.
Osteo-Men Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bone density is low, indicating osteoporosis or I have a slightly higher bone density but with another risk factor for bone fractures.
Osteo-Men Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of treatment with TPTD+cinacalcet compared to TPTD+PBO on lumbar spine BMD in men with low bone mass
Secondary outcome measures
Effects of treatment with TPTD+cinacalcet compared to TPTD+PBO on femoral neck BMD in men with low bone mass
Effects of treatment with TPTD+cinacalcet compared to TPTD+PBO on serum P1NP in men with low bone mass
Other outcome measures
Pharmacodynamic responses to TPTD+cinacalcet and to TPTD+PBO in men with low bone mass
Osteo-Men Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: teriparatide (TPTD) + the calcimimetic cinacalcetExperimental Treatment4 Interventions
Combination arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide [PTH (1-34)] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
Group II: teriparatide (TPTD) + placeboPlacebo Group4 Interventions
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide [PTH (1-34)] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590
Cinacalcet
2010
Completed Phase 4
~7170
Find a Location
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,506 Previous Clinical Trials
15,238,507 Total Patients Enrolled
10 Trials studying Osteoporosis
7,358 Patients Enrolled for Osteoporosis
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,236 Total Patients Enrolled
5 Trials studying Osteoporosis
57,387 Patients Enrolled for Osteoporosis
Dolores M. Shoback, MDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken osteoporosis drugs, including specific treatments, in specified time frames.I have taken oral steroids equivalent to 5 mg of prednisone or more in the last 3 months.I have changed my testosterone therapy dose or had androgen deprivation therapy in the last year.My calcium levels are too high or too low, or I have high urine calcium.I have had cancer other than non-melanoma skin cancer in the last 5 years.I do not have a history of heavy drinking, liver disease, or poor liver function.You need to have reliable bone density measurements at least two levels in your lower spine.I have a bone condition that is not osteoporosis.I had an episode of upper GI bleeding in the last 10 years not treated by surgery.You are allergic to teriparatide or any ingredients in Forteo.Your vitamin D levels are either too low (less than 20 ng/ml) or too high (more than 80 ng/ml) when tested.I have had a kidney stone in the last 5 years.My kidney function is very low (stage 4 or 5 CKD).I have had radiation for bone issues, osteosarcoma, or bone spread of cancer.My bone density is low, indicating osteoporosis or I have a slightly higher bone density but with another risk factor for bone fractures.I am not taking medication to lower my calcium levels.I have a history or risk of abnormal heart rhythms.I have a history of sudden blood pressure drops when standing up.I am not taking medications that affect CYP2D6 or CYP3A4 enzymes.My liver is not working well.My diabetes is not well-controlled (A1c >9%) or I am on thiazolidinedione treatment.Your thyroid hormone level is too low.I have heart problems that need medication.
Research Study Groups:
This trial has the following groups:- Group 1: teriparatide (TPTD) + the calcimimetic cinacalcet
- Group 2: teriparatide (TPTD) + placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is the combination of teriparatide (TPTD) and the calcimimetic cinacalcet deemed secure for patients?
"Our team's research yielded a score of 3 for teriparatide (TPTD) plus calcimimetic cinacalcet, since this is an approved Phase 4 treatment."
Answered by AI
What criteria must be met for a person to become an eligible participant in this clinical trial?
"This clinical trial is accepting 48 individuals aged between 60 and 85 with a DXA BMD T-score lower than or equal to -2.0 at either the lumbar spine, femoral neck, or total hip sites; alternatively, if the individual has a T-score below -1.5 in combination with other osteoporotic factors such as fragility fracture after age 50 years or parental history of hip fracture they may also qualify for enrollment. The procedure can only be conducted on two reliable vertebral levels without compression or hardware present."
Answered by AI
Are new participants being sought out for this trial?
"Yes, according to the information available on clinicaltrials.gov, this trial is still recruiting participants. It was first published in July 2019 and last updated in November 2022; 48 subjects are being enrolled from a single site."
Answered by AI
To what therapeutic condition is the combination of teriparatide (TPTD) and calcimimetic cinacalcet typically prescribed?
"Parathyroidectomy is typically managed by employing the combination of teriparatide (TPTD) and a calcimimetic cinacalcet. This remedy has also shown efficacy in treating parathyroid carcinoma, osteoporosis, and hypercalcemia."
Answered by AI
How many individuals are enrolled in this research project?
"Affirmative. From the information available on clinicaltrials.gov, it appears that this trial went live in July 2019 and is actively seeking volunteers for a 48-person cohort to be hosted at one site."
Answered by AI
Are participants of this trial required to be at least eighteen years old?
"This trial's inclusion criteria demand that participants are between 60 and 85 years old. Additionally, there are 16 trials for minors under 18 and 131 studies open to senior citizens over the age of 65."
Answered by AI
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