Investigating the effects of romosozumab on bone cells in postmenopausal women

Mechanisms of Anabolic Osteoporosis Therapy

This study is testing how a medication called romosozumab affects bone cells in postmenopausal women who are being treated for osteoporosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 45 Years and up
• Sex: Female
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: romosozumab, denosumab
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05688969 on ClinicalTrials.gov

What this trial studies

This study aims to explore how romosozumab affects bone cells in postmenopausal women undergoing treatment for osteoporosis. Participants will undergo paired iliac crest bone biopsies before starting therapy and again at either 3-6 weeks or 6-8 months after treatment initiation. The study is observational and does not randomize participants to different therapies, but rather to the timing of the second biopsy. This approach allows for a detailed examination of the drug's impact over time.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women over 45 years old who are prescribed romosozumab and meet FDA-defined indications for its use.

Not a fit: Patients with renal disease, elevated blood PTH levels, low vitamin D levels, or major psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how romosozumab works, potentially leading to improved treatment strategies for osteoporosis.

How similar studies have performed: While this study focuses on a specific mechanism of action for romosozumab, similar studies have shown promise in understanding osteoporosis treatments, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be offered enrollment. The FDA approved indication for romosozumab is: "the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy." Volunteers must be:

1. Female aged \> 45 years
2. Postmenopausal by either of the following criteria:

   1. \> 36 since last spontaneous menses
   2. \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years

Exclusion Criteria:

* renal disease (stage 4 CKD)
* elevated blood PTH (intact PTH \> 77 pg/ml).
* serum 25-OH vitamin D \< 20 ng/ml
* major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* known congenital or acquired bone disease other than osteoporosis.
* exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.
* exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.
* any prior exposure to romosozumab.

Where this trial is running

Boston, Massachusetts

• Mass General Brigham — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Benjamin Leder, MD — Massachusetts General Hospital
• Study coordinator: Mackenzie Jordan

Conditions Osteoporosis, Postmenopausal