Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Denosumab; Drug: Alendronate

• Registration Number: NCT03005678
• Lead Sponsor: Tuen Mun Hospital

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 Timeline

• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Study Start: 2017-04-01
• Primary Completion: 2019-11-01
• Status Verified: 2020-02
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	denosumab subcutaneous 60mg every 6 months
Alendronate	Alendronate	alendronate 70mg orally every week

Primary Outcome Measures

Name	Time	Method
bone mineral density at lumbar spine	month 12	BMD lumbar spine

Secondary Outcome Measures

Name	Time	Method
bone turnover markers	month 12	P1NP and osteocalcin
adverse events	month 12	adverse events
bone mineral density at the hip	month 12	BMD hip

Trial Locations

Locations (1)

Department of Medicine, Tuen Mun Hospital; 🇨🇳 Hong Kong, China