Mechanisms of Anabolic Osteoporosis Therapy

Description

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

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Study Overview

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Study Details

Study overview

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

Mechanisms of Anabolic Osteoporosis Therapy

Mechanisms of Anabolic Osteoporosis Therapy

Condition
Osteoporosis, Postmenopausal
Intervention / Treatment

-

Contacts and Locations

Boston

Mass General Brigham, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Benjamin Leder, MD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

2028-12