Skip to main content
OpenTrials
Completed

NCT Number: NCT03005678

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine, Tuen Mun Hospital

Hong Kong, 000, China

About this study

Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

  • Denosumab: a total of 2 doses in a period of 12 months
  • Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (women or men) >18 years of age
  • Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
  • Informed consent from patients.
  • Willing to comply with all study procedures

Exclusion criteria

  • Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
  • Premenopausal women who plan for pregnancy within 18 months of study entry.
  • Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
  • Patients with unexplained hypocalcemia.
  • Patients with serum creatinine level of >=200umol/L.

Treatment and study plan

Denosumab

Drug

active treatment group

Other names: prolia

Alendronate

Drug

comparator

Other names: fosamax

Primary outcomes

  1. bone mineral density at lumbar spine

    Time frame: month 12

    BMD lumbar spine

Secondary outcomes

  1. bone mineral density at the hip

    Time frame: month 12

    BMD hip

  2. bone turnover markers

    Time frame: month 12

    P1NP and osteocalcin

  3. adverse events

    Time frame: month 12

    adverse events

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Registry information

Official study title

Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 29, 2016
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.