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Understanding Romosozumab's Effect on Bone Cells in Postmenopausal Osteoporosis

This study is looking at how the osteoporosis medication romosozumab affects bone cells in women who have gone through menopause. Researchers want to understand these effects during the early (3-6 weeks) and later (6-8 months) stages of treatment. You may be able to join if you are a postmenopausal woman, aged 45 or older, and your doctor has prescribed romosozumab for your osteoporosis because you are at high risk for fractures. The main goal is to measure the number of osteoblast progenitor cells (cells that develop into bone-forming cells) at these different time points. The study is currently unclear on its recruitment status and plans to enroll 16 participants.

Study design
This interventional study is not randomized to test the drug's effectiveness, but participants will be randomly assigned to either an early or late second biopsy. It plans to enroll 16 women.
What's involved
You will have a bone biopsy before starting romosozumab, and then another identical biopsy on the opposite side either 3-6 weeks or 6-8 months after starting treatment.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 3-6 weeks or 6-8 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05688969

Mechanisms of Anabolic Osteoporosis Therapy

Recruiting
NAAges 45+Interventional
Massachusetts General Hospital
~16 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:early versus late biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Osteoblast progenitor cell numbers
Measured over 3-6 weeks (early) versus 6-8 months (late)

Conditions

Osteoporosis, Postmenopausal

Explore related trials

Osteoporosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Benjamin Leder, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Mackenzie Jordan
[email protected]
617-726-6129
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Osteoblast progenitor cell numbers3-6 weeks (early) versus 6-8 months (late)

    The investigators are testing the mechanistic hypothesis that romosozumab treatment increases osteoblast progenitor cell numbers at early, but not late, treatment time points.