Anabolic Therapy for Osteoporosis

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin Leder, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

Research Team

Benjamin Leder, MD

Principal Investigator

Mass. General Hospital

Eligibility Criteria

This trial is for postmenopausal women at high risk of fracture. Participants must not have severe kidney disease, uncontrolled skin conditions, very low or high calcium levels, certain bone diseases other than osteoporosis, recent heart issues, or a history of significant lung disease. They should not have used specific osteoporosis treatments recently and must not be currently abusing substances.

Inclusion Criteria

I am a postmenopausal woman at high risk for breaking bones.

Exclusion Criteria

My kidney function is severely reduced.

Your blood test shows high levels of alkaline.

I have used oral bisphosphonates or denosumab in the last year.

See 24 more

Treatment Details

Interventions

Denosumab (Monoclonal Antibodies)
Romosozumab (Monoclonal Antibodies)

Trial OverviewThe study compares two FDA-approved medications for treating osteoporosis: Denosumab and Romosozumab. It aims to understand their effects in preventing fractures in postmenopausal women who are at a higher risk.

Participant Groups

2Treatment groups

Active Control

Group I: RomosozumabActive Control1 Intervention

Group II: Romosozumab and denosumabActive Control2 Interventions

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: