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Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Primary Purpose

Osteoporosis, Postmenopausal, Osteoporosis

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

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

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

Inclusion Criteria:

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Exclusion Criteria:

  • no significant previous use of bone health modifying treatments
  • hip fracture within one year of enrollment
  • known congenital or acquired bone disease other than osteoporosis
  • significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
  • abnormal calcium or parathyroid hormone level
  • serum vitamin D <20 ng/dL
  • anemia (hematocrit <32%)
  • history of malignancy (except non-melanoma skin carcinoma)
  • excessive alcohol use or substance abuse
  • extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
  • known contraindications to denosumab, alendronate, or raloxifene

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Denosumab and Raloxifene

Denosumab and Alendronate

Arm Description

denosumab and raloxifene

denosumab and alendronate

Outcomes

Primary Outcome Measures

Serum c-telopeptide (CTX)
Change in serum CTX between month 12 and month 18
Bone mineral density (BMD)
Change in PA spine BMD between month 24 and month 36

Secondary Outcome Measures

Full Information

First Posted
August 6, 2018
Last Updated
June 5, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03623633
Brief Title
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Official Title
Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Denosumab and Raloxifene
Arm Type
Active Comparator
Arm Description
denosumab and raloxifene
Arm Title
Denosumab and Alendronate
Arm Type
Active Comparator
Arm Description
denosumab and alendronate
Intervention Type
Drug
Intervention Name(s)
denosumab
Other Intervention Name(s)
Prolia
Intervention Description
denosumab 60 milligrams subcutaneously every 6 months
Intervention Type
Drug
Intervention Name(s)
alendronate
Other Intervention Name(s)
Fosamax
Intervention Description
alendronate 70 milligrams weekly
Intervention Type
Drug
Intervention Name(s)
raloxifene
Other Intervention Name(s)
Evista
Intervention Description
raloxifene 60 milligrams daily
Primary Outcome Measure Information:
Title
Serum c-telopeptide (CTX)
Description
Change in serum CTX between month 12 and month 18
Time Frame
Month 12 to 18 months
Title
Bone mineral density (BMD)
Description
Change in PA spine BMD between month 24 and month 36
Time Frame
Month 24 to 36 months

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: women aged 45+ postmenopausal osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines Exclusion Criteria: no significant previous use of bone health modifying treatments hip fracture within one year of enrollment known congenital or acquired bone disease other than osteoporosis significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease abnormal calcium or parathyroid hormone level serum vitamin D <20 ng/dL anemia (hematocrit <32%) history of malignancy (except non-melanoma skin carcinoma) excessive alcohol use or substance abuse extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months known contraindications to denosumab, alendronate, or raloxifene
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Tsai, MD
Organizational Affiliation
MGH
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

Plan to Share IPD
Undecided

Learn more about this trial

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

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