Osteoporosis
Conditions
Keywords
glucocorticoids, steroids, osteoporosis
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)
Interventions
DRUGDenosumab
active treatment group
DRUGAlendronate
comparator
Sponsors
Tuen Mun Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density at lumbar spine | month 12 | BMD lumbar spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density at the hip | month 12 | BMD hip |
| bone turnover markers | month 12 | P1NP and osteocalcin |
| adverse events | month 12 | adverse events |
Countries
China
Outcome results
None listed