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Mechanisms of Anabolic Osteoporosis Therapy

Primary Purpose

Osteoporosis, Postmenopausal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
early versus late biopsy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis, Postmenopausal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: 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 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.

Sites / Locations

  • Mass General BrighamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early Biopsy

Late Biopsy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2023
Last Updated
August 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05688969
Brief Title
Mechanisms of Anabolic Osteoporosis Therapy
Official Title
Mechanisms of Anabolic Osteoporosis Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
Detailed Description
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 randomized clinical trial testing the efficacy of a drug - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Biopsy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Late Biopsy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
early versus late biopsy
Intervention Description
early (3-6 weeks) versus late (6-8 months) biopsy
Primary Outcome Measure Information:
Title
Osteoblast progenitor cell numbers
Description
The investigators are testing the mechanistic hypothesis that romosozumab treatment increases osteoblast progenitor cell numbers at early, but not late, treatment time points.
Time Frame
3-6 weeks (early) versus 6-8 months (late)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mackenzie Jordan
Phone
617-726-6129
Email
MRJORDAN@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Leder, MD
Organizational Affiliation
Mass General Brigham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mackenzie Jordan
Email
MRJORDAN@mgh.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

Mechanisms of Anabolic Osteoporosis Therapy

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