Combination Therapy for Osteoporosis in Men
(Osteo-Men Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of two drugs, Teriparatide and Cinacalcet, to treat osteoporosis in older men. Teriparatide builds bone mass, while Cinacalcet helps bone-forming cells work better. The study aims to see if using both drugs together improves bone strength more than using Teriparatide alone.
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications. The trial excludes participants who have used osteoporosis drugs like bisphosphonates, denosumab, or teriparatide within specific time frames before joining. Additionally, drugs affecting calcium levels or metabolized through certain liver enzymes are also restricted.
Is the combination therapy for osteoporosis in men, including teriparatide, generally safe?
How is the drug Teriparatide unique in treating osteoporosis in men?
What data supports the effectiveness of the drug combination therapy for osteoporosis in men?
Teriparatide, a component of the combination therapy, is shown to increase bone density and reduce fractures in men with osteoporosis, although the evidence is stronger in women. Observational data suggest it may reduce vertebral fractures in men, and it is well tolerated with a good safety profile.12489
Who Is on the Research Team?
Dolores M Shoback, MD
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants take only calcium and vitamin D supplements to stabilize baseline conditions
Treatment
Participants receive daily subcutaneous injections of TPTD and either cinacalcet or placebo for 11 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cinacalcet
- Teriparatide or human parathyroid hormone (PTH) 1-34
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
University of California, San Francisco
Collaborator