Denosumab Versus Bisphosphonates (Alendronate) in GIOP

NCT03005678 | Completed Phase 4

• 1 other identifier: CREC/16
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis

Keywords

glucocorticoids, steroids, osteoporosis

Outcome Measures

Primary Outcomes (1)

• bone mineral density at lumbar spine

  BMD lumbar spine

  month 12

Secondary Outcomes (3)

• bone mineral density at the hip

  month 12

• bone turnover markers

  month 12

• adverse events

  month 12

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

denosumab subcutaneous 60mg every 6 months

Drug: Denosumab

Alendronate

PLACEBO COMPARATOR

alendronate 70mg orally every week

Drug: Alendronate

Interventions

Denosumab DRUG

active treatment group

Also known as: prolia

Denosumab

Alendronate DRUG

comparator

Also known as: fosamax

Alendronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, 000, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• CC Mok

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: December 29, 2016
• Study Start: April 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)