Recruiting

Anabolic Osteoporosis Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT05688969

Conditions

Osteoporosis, Postmenopausal

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

early versus late biopsy

Study Details

Brief summary:

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

Conditions

Osteoporosis, Postmenopausal

Study ID

NCT05688969

Start date

Jun 14, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Early Biopsy

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.

active comparator: Late Biopsy

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.

Interventions

early versus late biopsy

early (3-6 weeks) versus late (6-8 months) biopsy

Primary outcome measure

  • Osteoblast progenitor cell numbers [ Time Frame: 3-6 weeks (early) versus 6-8 months (late) ]

Central Contacts and Locations

Central contacts

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mackenzie Jordan

MRJORDAN@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-18.