Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2017-04-01
2020-02-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Denosumab
denosumab subcutaneous 60mg every 6 months
Denosumab
active treatment group
Alendronate
alendronate 70mg orally every week
Alendronate
comparator
Interventions
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Denosumab
active treatment group
Alendronate
comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Tuen Mun Hospital
OTHER_GOV
Responsible Party
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Chi Chiu Mok
Principal investigator
Principal Investigators
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CC Mok
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Department of Medicine, Tuen Mun Hospital
Hong Kong, , China
Countries
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Other Identifiers
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CREC/16
Identifier Type: -
Identifier Source: org_study_id
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