Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Tuen Mun Hospital140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Osteoporosis

Interventions

DenosumabDRUG

active treatment group

AlendronateDRUG

comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, China

Outcomes

Primary Outcomes

bone mineral density at lumbar spine

BMD lumbar spine

Time frame: month 12

Secondary Outcomes

bone mineral density at the hip

BMD hip

Time frame: month 12

bone turnover markers

P1NP and osteocalcin

Time frame: month 12

adverse events

Time frame: month 12

Data from ClinicalTrials.gov

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