Anabolic Therapy Timing for Osteoporosis

Recruiting in Palo Alto (17 mi)

Overseen by Benjamin Leder, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Must be taking: Romosozumab

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

Disqualifiers: Renal disease, Psychiatric disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you should not have taken oral bisphosphonates in the past 3 months, denosumab in the last 12 months, or intravenous bisphosphonates in the past 24 months. Also, you should not have used estrogens, SERMs, calcitonin, or glucocorticoids for more than 14 days in the past 2 months.

What data supports the effectiveness of the drug Romosozumab for osteoporosis?

Research shows that Romosozumab significantly increases bone mineral density (the strength of bones) and bone formation markers in patients with osteoporosis, making it more effective than other treatments like teriparatide. It also controls bone resorption (the process of breaking down bone), which enhances its ability to strengthen bones. ^{1 2 3 4 5}

Is romosozumab safe for humans?

Romosozumab has been studied for safety in treating osteoporosis, with research indicating it is generally safe but may have potential cardiovascular risks (related to the heart and blood vessels). ^{1 2 4 6 7}

How is the drug Romosozumab unique in treating osteoporosis?

Romosozumab is unique because it is a monoclonal antibody that both promotes bone formation and inhibits bone resorption by targeting sclerostin, a protein that regulates bone formation. This dual action leads to rapid and significant increases in bone mineral density, making it more effective than other treatments like bisphosphonates or parathyroid hormone analogs, and it is administered once a month through two injections. ^{1 5 8 9 10}

Research Team

Benjamin Leder, MD

Principal Investigator

Mass General Brigham

Eligibility Criteria

This trial is for postmenopausal women over 45 with osteoporosis who are not at high risk for bone procedures and have been prescribed romosozumab. They mustn't have other bone diseases, recent use of certain hormones or steroids, major psychiatric conditions, low vitamin D levels, high PTH levels, prior romosozumab exposure, substance abuse issues, or severe kidney disease.

Inclusion Criteria

I am postmenopausal, with no period for over 3 years or had a hysterectomy with high FSH levels if I'm under 60.

I am eligible for romosozumab treatment according to FDA guidelines.

Not at increased risk for a bone marrow aspirate or bone biopsy

Exclusion Criteria

You drink too much alcohol or use drugs in a way that would make it hard for you to understand the study or follow the study rules.

I have previously been treated with romosozumab.

I haven't taken oral bisphosphonates in the last 3 months, denosumab in the last year, or IV bisphosphonates in the last 2 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Biopsy

Participants undergo a bone biopsy procedure prior to starting romosozumab therapy

1 day

1 visit (in-person)

Early Treatment

Participants receive romosozumab therapy and undergo a second bone biopsy 3-6 weeks after starting therapy

3-6 weeks

1 visit (in-person)

Late Treatment

Participants continue romosozumab therapy and undergo a second bone biopsy 6-8 months after starting therapy

6-8 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biopsy (Procedure)
• Romosozumab (Monoclonal Antibodies)

Trial Overview The study examines the effects of a medication called romosozumab on bone cells in women with osteoporosis. It compares results from early versus late treatment phases to understand how this drug works over time.

Participant Groups

Group I: Late Biopsy Active Control 1 Intervention

The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

Group II: Early Biopsy Active Control 1 Intervention

The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mass General Brigham Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. Ebina, K., Hirao, M., Tsuboi, H., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab treatment in postmenopausal women with osteoporosis: a meta-analysis of randomized controlled trials. Liu, Y., Cao, Y., Zhang, S., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. Ebina, K., Tsuboi, H., Nagayama, Y., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study. Inage, K., Orita, S., Eguchi, Y., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab/CDP7851 for the treatment of osteoporosis. Sim, IW., Ebeling, PR.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk. Fixen, C., Tunoa, J.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis. Nealy, KL., Harris, KB.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Romosozumab in the Management of Osteoporosis: Focus on Patient Selection and Perspectives. Lim, SY., Bolster, MB.[2022]

Romosozumab is an effective treatment for severe osteoporosis in postmenopausal women, significantly reducing vertebral and clinical fracture risk compared to placebo and oral alendronate in pivotal phase III trials involving monthly doses over 12 months.

The treatment not only increased bone mineral density significantly but also maintained these benefits even after transitioning to other osteoporosis therapies, indicating its potential as a valuable option for women at high risk of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab: A Review in Postmenopausal Osteoporosis. Paik, J., Scott, LJ.[2021]

Romosozumab effectively increases bone mineral density and reduces fracture risk in osteoporosis patients, with clinical studies showing a 28-36% reduction in vertebral fractures and a 42% reduction in nonvertebral fractures.

While romosozumab is generally safe, with only about 5% of patients experiencing injection site reactions, there is a potential risk of cardiovascular side effects, although serious complications were not significantly higher than in the control group during phase III studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romosozumab: a novel bone anabolic treatment option for osteoporosis? Kerschan-Schindl, K.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Romosozumab treatment in postmenopausal women with osteoporosis: a meta-analysis of randomized controlled trials. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. [2021]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Romosozumab/CDP7851 for the treatment of osteoporosis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Utility of Romosozumab in the Management of Osteoporosis: Focus on Patient Selection and Perspectives. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Romosozumab: A Review in Postmenopausal Osteoporosis. [2021]

10. Austria pubmed.ncbi.nlm.nih.gov

Romosozumab: a novel bone anabolic treatment option for osteoporosis? [2020]