Actively Recruiting

Phase Not Applicable
Age: 45Years +
FEMALE
NCT05688969

Mechanisms of Anabolic Osteoporosis Therapy

Led by Massachusetts General Hospital · Updated on 2025-12-18

16

Participants Needed

1

Research Sites

285 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Mechanisms of Anabolic Osteoporosis Therapy

Who Can Participate

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged over 45 years
  • Postmenopausal by either more than 36 months since last spontaneous menses or more than 36 months since hysterectomy plus serum FSH over 40 units/liter if under 60 years
  • Prescribed romosozumab by treating physician
  • Meet FDA-defined indication for romosozumab use in osteoporosis (high risk for fracture or intolerance/failure of other therapies)
  • Not at increased risk for bone marrow aspirate or bone biopsy
Not Eligible

You will not qualify if you...

  • Renal disease stage 4 chronic kidney disease
  • Elevated intact parathyroid hormone over 77 pg/ml
  • Serum 25-OH vitamin D below 20 ng/ml
  • Major psychiatric disease preventing informed consent or protocol completion
  • Excessive alcohol use or substance abuse preventing informed consent or protocol completion
  • Known congenital or acquired bone disease other than osteoporosis
  • Exposure to oral bisphosphonates within past 3 months
  • Exposure to denosumab within past 12 months
  • Exposure to intravenous bisphosphonates within past 24 months
  • Exposure to estrogens, selective estrogen receptor modulators, or calcitonin, or glucocorticoids for more than 14 days in past 2 months
  • Any prior exposure to romosozumab

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mass General Brigham

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Mackenzie Jordan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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