Anabolic Therapy for Osteoporosis

Overseen By Savannah Ryan

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

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

Disqualifiers: Kidney disease, Hypercalcemia, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Benjamin Leder, MD

Principal Investigator

Mass. General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Romosozumab alone or in combination with Denosumab for osteoporosis treatment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Denosumab
• Romosozumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Romosozumab Active Control 1 Intervention

Group II: Romosozumab and denosumab Active Control 2 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:

• Treatment of osteoporosis in postmenopausal women
• Treatment of bone loss associated with hormone ablation therapy for prostate cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+