Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Denosumab; Drug: Alendronate

Study type: Interventional

Funder types: Other

Identifiers

NCT03005678

CREC/16

Details and patient eligibility

About

A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Full 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)

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

Denosumab

Active Comparator group

Description:

denosumab subcutaneous 60mg every 6 months

Treatment:

Drug: Denosumab

Alendronate

Placebo Comparator group

Description:

alendronate 70mg orally every week

Treatment:

Drug: Alendronate