Investigating the effects of romosozumab on bone cells in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mass General Brigham
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Benjamin Leder, MD — Massachusetts General Hospital
• Study coordinator: Mackenzie Jordan
• Email: MRJORDAN@mgh.harvard.edu
• Phone: 617-726-6129

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How mechanical loading and bone loss change motor neuron reflexes

  This study will test whether weight-bearing activities and whole-body vibration change spinal reflex (H-reflex) responses in postmenopausal women with and without osteoporosis.

  Recruiting Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Bahçelievler, Istanbul · NCT07253493

• Comparing two treatment regimens for osteoporosis in postmenopausal women

  This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT06938152

• Evaluating stress urinary incontinence in postmenopausal women with osteoporosis

  This study looks at how common stress urinary incontinence is in postmenopausal women with and without osteoporosis, and how it affects their quality of life.

  Recruiting Beylikduzu State Hospital · Istanbul · NCT06655701

• Combining two medications for treating postmenopausal osteoporosis

  This study is testing whether combining two approved medications can help women over 45 with postmenopausal osteoporosis improve their bone health and lower their risk of fractures.

  Recruiting Phase 4 Massachusetts General Hospital · Boston, Massachusetts · NCT06558188

• Virtual registry for menopause and perimenopause in Australia

  This study is creating an online registry to collect information from Australian women about their experiences with menopause and perimenopause to help improve healthcare and support for them.

  Recruiting Bespoke Clinical Research · Adelaide · NCT06487130

• Evaluating treatments after osteoanabolic therapy for osteoporosis

  This study is testing different follow-up treatments for Caucasian women with severe osteoporosis after they’ve finished a specific therapy to see which one helps improve their bone health the most.

  Recruiting at 8 sites 424 General Military Hospital · Athens and 7 other locations · NCT06164795

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.