Denosumab Versus Bisphosphonates (Alendronate) in GIOP

February 11, 2020 updated by: Chi Chiu Mok, Tuen Mun Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China, 000
        • Department of Medicine, Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Denosumab
denosumab subcutaneous 60mg every 6 months
Drug: Denosumab
active treatment group
Other Names:
  • prolia
PLACEBO_COMPARATOR: Alendronate
alendronate 70mg orally every week
Drug: Alendronate
comparator
Other Names:
  • fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density at lumbar spine
Time Frame: month 12
BMD lumbar spine
month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density at the hip
Time Frame: month 12
BMD hip
month 12
bone turnover markers
Time Frame: month 12
P1NP and osteocalcin
month 12
adverse events
Time Frame: month 12
adverse events
month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Investigators

  • Principal Investigator: CC Mok, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

December 24, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (ESTIMATE)

December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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