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Anabolic Therapy in Postmenopausal Osteoporosis

Primary Purpose

Postmenopausal Osteoporosis

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Romosozumab
Denosumab
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal women at high risk of fracture

Exclusion Criteria:

  • Prior therapy exclusions

    1. current use or use in the past 12 months of oral bisphosphonates or denosumab
    2. current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
    3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
    4. any current or previous use of romosozumab, strontium, teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

  1. Confirmed serum alkaline greater than 2 times the upper normal limit).
  2. Stage 4 or 5 chronic kidney disease (GFR less than 30)
  3. Hypercalcemia (Calcium greater than 10.5 mg/dL)
  4. Hypocalcemia (Calcium less than 8.8 mg/dL)
  5. Elevated blood parathyroid hormone (PTH) (intact PTH greater than 65 pg/ml)
  6. Serum 25-hydroxy vitamin D less than 20 ng/ml
  7. Hematocrit less than 32%.
  8. History of malignancy (except basal cell carcinoma).
  9. Significant pulmonary disease
  10. History of myocardial infarction or stroke within the preceding year.
  11. History of unstable angina or transient ischemic attack in the past year.
  12. Current atrial fibrillation.
  13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
  14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  15. Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  16. Uncontrolled eczema
  17. Congenital or acquired bone disease other than osteoporosis
  18. Known sensitivity to denosumab or any of its excipients.
  19. Known sensitivity to romosozumab or any of its excipients.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Romosozumab and denosumab

Romosozumab

Arm Description

Outcomes

Primary Outcome Measures

Total hip areal bone mineral density
Change in total hip bone density between month 0 and month 12

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
May 11, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05010590
Brief Title
Anabolic Therapy in Postmenopausal Osteoporosis
Official Title
Anabolic Therapy in Postmenopausal Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romosozumab and denosumab
Arm Type
Active Comparator
Arm Title
Romosozumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Intervention Description
Monthly romosozumab
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
Every 6 months denosumab
Primary Outcome Measure Information:
Title
Total hip areal bone mineral density
Description
Change in total hip bone density between month 0 and month 12
Time Frame
Month 0 to 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal women at high risk of fracture Exclusion Criteria: Prior therapy exclusions current use or use in the past 12 months of oral bisphosphonates or denosumab current use or use within the past 3 months of estrogens, SERMs, or calcitonin. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months any current or previous use of romosozumab or strontium current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate. Other exclusions Confirmed serum alkaline greater than 2 times the upper normal limit. Stage 4 or 5 chronic kidney disease (GFR less than 30) Hypercalcemia (Ca greater than 10.5 mg/dL) Hypocalcemia (Ca less than 8.8 mg/dL) Elevated blood PTH (intact PTH greater than 77 pg/mL) Serum 25-OH vitamin D less than 20 ng/mL HCT less than 32%. History of malignancy (except basal cell carcinoma). Significant pulmonary disease History of myocardial infarction or stroke within the preceding year. History of unstable angina or transient ischemic attack in the past year. Current atrial fibrillation. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events. 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 in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. Uncontrolled eczema Congenital or acquired bone disease other than osteoporosis. Known sensitivity to denosumab or any of its excipients. Known sensitivity to romosozumab or any of its excipients. History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Leder, MD
Organizational Affiliation
Mass. General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Anabolic Therapy in Postmenopausal Osteoporosis

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