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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

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.


Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Osteoporosis Drug: denosumab Drug: alendronate Drug: raloxifene Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Active Comparator: Denosumab and Raloxifene
denosumab and raloxifene
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Name: Prolia

Drug: raloxifene
raloxifene 60 milligrams daily
Other Name: Evista

Active Comparator: Denosumab and Alendronate
denosumab and alendronate
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Name: Prolia

Drug: alendronate
alendronate 70 milligrams weekly
Other Name: Fosamax




Primary Outcome Measures :
  1. Serum c-telopeptide (CTX) [ Time Frame: 18 months ]
    Change in serum CTX between month 12 and month 18



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623633


Contacts
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Contact: Natalie David, BA 6177266129 ndavid2@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Grace Sassana    617-724-2035    gsassana@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Joy Tsai, MD MGH

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Responsible Party: Joy Tsai, Instructor, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03623633     History of Changes
Other Study ID Numbers: 2018P001612
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Alendronate
Raloxifene Hydrochloride
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators