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Comparative Antiresorptive Efficacy Discontinuation of Denosumab

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ClinicalTrials.gov Identifier: NCT03623633
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Joy Tsai, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 6, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
Serum c-telopeptide (CTX) [ Time Frame: 18 months ]
Change in serum CTX between month 12 and month 18
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03623633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Official Title  ICMJE Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
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.

The proposed study will help us determine the 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis, Postmenopausal
  • Osteoporosis
Intervention  ICMJE
  • Drug: denosumab
    denosumab 60 milligrams subcutaneously every 6 months
    Other Name: Prolia
  • Drug: alendronate
    alendronate 70 milligrams weekly
    Other Name: Fosamax
  • Drug: raloxifene
    raloxifene 60 milligrams daily
    Other Name: Evista
Study Arms  ICMJE
  • Active Comparator: Denosumab and Raloxifene
    denosumab and raloxifene
    Interventions:
    • Drug: denosumab
    • Drug: raloxifene
  • Active Comparator: Denosumab and Alendronate
    denosumab and alendronate
    Interventions:
    • Drug: denosumab
    • Drug: alendronate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Postmenopausal women
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Natalie David, BA 6177266129 ndavid2@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623633
Other Study ID Numbers  ICMJE 2018P001612
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joy Tsai, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joy Tsai, MD MGH
PRS Account Massachusetts General Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP