Back to resultsDenosumab Versus Bisphosphonates (Alendronate) in GIOP
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Denosumab
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring glucocorticoids, steroids, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Adults (women or men) >18 years of age
- Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
- Informed consent from patients.
- Willing to comply with all study procedures
Exclusion Criteria:
- Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
- Premenopausal women who plan for pregnancy within 18 months of study entry.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with unexplained hypocalcemia.
- Patients with serum creatinine level of >=200umol/L.
Sites / Locations
- Department of Medicine, Tuen Mun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Denosumab
Alendronate
Arm Description
denosumab subcutaneous 60mg every 6 months
alendronate 70mg orally every week
Outcomes
Primary Outcome Measures
bone mineral density at lumbar spine
BMD lumbar spine
Secondary Outcome Measures
bone mineral density at the hip
BMD hip
bone turnover markers
P1NP and osteocalcin
adverse events
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03005678
Brief Title
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
Official Title
Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuen Mun Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Denosumab: a total of 2 doses in a period of 12 months
Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
glucocorticoids, steroids, osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Denosumab
Arm Type
Active Comparator
Arm Description
denosumab subcutaneous 60mg every 6 months
Arm Title
Alendronate
Arm Type
Placebo Comparator
Arm Description
alendronate 70mg orally every week
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
prolia
Intervention Description
active treatment group
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
fosamax
Intervention Description
comparator
Primary Outcome Measure Information:
Title
bone mineral density at lumbar spine
Description
BMD lumbar spine
Time Frame
month 12
Secondary Outcome Measure Information:
Title
bone mineral density at the hip
Description
BMD hip
Time Frame
month 12
Title
bone turnover markers
Description
P1NP and osteocalcin
Time Frame
month 12
Title
adverse events
Description
adverse events
Time Frame
month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (women or men) >18 years of age
Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
Informed consent from patients.
Willing to comply with all study procedures
Exclusion Criteria:
Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
Premenopausal women who plan for pregnancy within 18 months of study entry.
Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
Patients with unexplained hypocalcemia.
Patients with serum creatinine level of >=200umol/L.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC Mok
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Tuen Mun Hospital
City
Hong Kong
ZIP/Postal Code
000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
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