Mechanisms of Anabolic Osteoporosis Therapy

Conditions

• Osteoporosis, Postmenopausal

Eligibility Criteria

Sex

FEMALE

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jun 14, 2023

Status verified

Dec 2025

Primary completion

Feb 29, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

16 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

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.

Primary Outcome Measure

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

Central Contacts

• Mackenzie Jordan
  617-726-6129
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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