Mechanisms of Anabolic Osteoporosis Therapy

NCT05688969 | Recruiting DMC

• 1 other identifier: 1P50AR080596-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Osteoblast progenitor cell numbers

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

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

Study Arms (2)

Early Biopsy

ACTIVE COMPARATOR

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.

Other: early versus late biopsy

Late Biopsy

ACTIVE COMPARATOR

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.

Other: early versus late biopsy

Interventions

early versus late biopsy OTHER

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

Early Biopsy; Late Biopsy

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Female aged \> 45 years
• Postmenopausal by either of the following criteria:
• \> 36 since last spontaneous menses
• \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benjamin Leder, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mackenzie Jordan

CONTACT

617-726-6129; MRJORDAN@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 1:1 allocation

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)