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Denosumab Versus Bisphosphonates (Alendronate) in GIOP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03005678
Recruitment Status : Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital

Tracking Information
First Submitted Date  ICMJE December 24, 2016
First Posted Date  ICMJE December 29, 2016
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2017)
bone mineral density at lumbar spine [ Time Frame: month 12 ]
BMD lumbar spine
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
bone mineral density at lumbar spine [ Time Frame: month 12 ]
Change History Complete list of historical versions of study NCT03005678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2017)
  • bone mineral density at the hip [ Time Frame: month 12 ]
    BMD hip
  • bone turnover markers [ Time Frame: month 12 ]
    P1NP and osteocalcin
  • adverse events [ Time Frame: month 12 ]
    adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • bone mineral density at the hip [ Time Frame: month 12 ]
  • bone turnover markers [ Time Frame: month 12 ]
  • adverse events [ Time Frame: month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Denosumab Versus Bisphosphonates (Alendronate) in GIOP
Official Title  ICMJE Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
Brief Summary A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
Detailed Description

Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

  1. Denosumab: a total of 2 doses in a period of 12 months
  2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Denosumab
    active treatment group
    Other Name: prolia
  • Drug: Alendronate
    comparator
    Other Name: fosamax
Study Arms  ICMJE
  • Active Comparator: Denosumab
    denosumab subcutaneous 60mg every 6 months
    Intervention: Drug: Denosumab
  • Placebo Comparator: Alendronate
    alendronate 70mg orally every week
    Intervention: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 28, 2016)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults (women or men) >18 years of age
  2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
  3. Informed consent from patients.
  4. Willing to comply with all study procedures

Exclusion Criteria:

  1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
  2. Premenopausal women who plan for pregnancy within 18 months of study entry.
  3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
  4. Patients with unexplained hypocalcemia.
  5. Patients with serum creatinine level of >=200umol/L.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03005678
Other Study ID Numbers  ICMJE CREC/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chi Chiu Mok, Tuen Mun Hospital
Study Sponsor  ICMJE Tuen Mun Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: CC Mok Principal Investigator
PRS Account Tuen Mun Hospital
Verification Date September 2019

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