Apply to Trial

Compensation: Varies

Number of Visits: 11

Duration: 48 weeks

40 Participants Needed

Combination Therapy for Osteoporosis in Men
(Osteo-Men Trial)

Overseen ByAnne L Schafer, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must be taking: Teriparatide

Must not be taking: Bisphosphonates, Denosumab, Antidepressants, others

Disqualifiers: Metabolic bone disease, Cancer, Diabetes, others

Prior Safety DataThis treatment has passed at least one previous human 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?

Teriparatide, a part of the combination therapy, is generally well tolerated and has a good safety profile, but it may cause side effects like high calcium levels in the blood and urine, and there is a warning about a potential risk of bone cancer based on animal studies.¹ ² ³ ⁴ ⁵

How is the drug Teriparatide unique in treating osteoporosis in men?

Teriparatide is unique because it is a bone-building drug that directly stimulates bone formation, unlike most other treatments that work by slowing bone loss. It is the only drug approved specifically for treating osteoporosis in men and is administered through daily self-injections.¹ ² ⁴ ⁶ ⁷

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.¹ ² ⁴ ⁸ ⁹

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

You need to have reliable bone density measurements at least two levels in your lower spine.

My bone density is low, indicating osteoporosis or I have a slightly higher bone density but with another risk factor for bone fractures.

Exclusion 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.

See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Run-in

Participants take only calcium and vitamin D supplements to stabilize baseline conditions

4 weeks

1 visit (in-person)

Treatment

Participants receive daily subcutaneous injections of TPTD and either cinacalcet or placebo for 11 months

48 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

Cinacalcet
Teriparatide or human parathyroid hormone (PTH) 1-34

Trial Overview 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.

How Is the Trial Designed?

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Teriparatide, a treatment for postmenopausal osteoporosis and osteoporosis in men, has been used for over 5 years, providing substantial data on its long-term safety, particularly regarding its registered dose of 20 microg/day.

While teriparatide is effective, there are important safety considerations, including the potential for hypercalcemia, hypercalciuria, and hyperuricemia, as well as a 'black-box' warning from the FDA about the risk of osteogenic sarcoma observed in rat studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of parathyroid hormone for the treatment of osteoporosis.Miller, PD.[2021]