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Denosumab Versus Bisphosphonates (Alendronate) in GIOP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03005678
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : May 24, 2018
Information provided by (Responsible Party):
Chi Chiu Mok, 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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Denosumab Drug: Alendronate Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Denosumab
denosumab subcutaneous 60mg every 6 months
Drug: Denosumab
active treatment group
Other Name: prolia

Placebo Comparator: Alendronate
alendronate 70mg orally every week
Drug: Alendronate
Other Name: fosamax

Primary Outcome Measures :
  1. bone mineral density at lumbar spine [ Time Frame: month 12 ]
    BMD lumbar spine

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03005678

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Contact: CC Mok 852-24685389
Contact: Connie Lo 852-24685389

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Department of Medicine, Tuen Mun Hospital Recruiting
Hong Kong, China, 000
Contact: Chi Chiu Mok, MD, FRCP    (852) 2468 5386   
Principal Investigator: Chi Chiu Mok, MD, FRCP         
Sponsors and Collaborators
Tuen Mun Hospital
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Principal Investigator: CC Mok Principal Investigator

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Responsible Party: Chi Chiu Mok, Principal investigator, Tuen Mun Hospital Identifier: NCT03005678     History of Changes
Other Study ID Numbers: CREC/16
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
glucocorticoids, steroids, osteoporosis

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists