Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

NCT01465568 | Completed Phase 4 DMC

• 1 other identifier: CREC/984/11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

Conditions

Osteoporosis

Keywords

osteoporosis; denosumab; RANKL; glucocorticoids

Outcome Measures

Primary Outcomes (1)

• bone mineral density (BMD) changes at the lumbar spine

  baseline, 6 months and 12 months

Secondary Outcomes (4)

• BMD changes in the total hip and femoral neck

  baseline, 6 months and 12 months

• bone turnover markers

  baseline, 6 months and 12 months

• New vertebral fractures

  12 months

• adverse events

  12 months

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

denosumab

Drug: Denosumab

bisphosphonates

ACTIVE COMPARATOR

continuation of bisphosphonates

Drug: bisphosphonates

Interventions

Denosumab DRUG

60mg subcutaneous injection 6 monthly for 2 doses

Also known as: Prolia

Denosumab

bisphosphonates DRUG

continue present bisphosphonate treatment

Also known as: continuation of bisphosphonates in their usual dosages

bisphosphonates

Eligibility Criteria

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

You may qualify if:

• Women or adult men (\>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.
• A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
• Having received oral bisphosphonate treatment for at least 2 years.
• Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores \< -2.5 or Z scores \< -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.
• Informed consent from patients.

You may not qualify if:

• Patients with previous use of denosumab or teriparatide.
• Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
• 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)

Tuen Mun Hospital

Hong Kong, China

Location

Related Publications (1)

• Mok CC, Ho LY, Ma KM. Switching of oral bisphosphonates to denosumab in chronic glucocorticoid users: a 12-month randomized controlled trial. Bone. 2015 Jun;75:222-8. doi: 10.1016/j.bone.2015.03.002. Epub 2015 Mar 8.

  PMID: 25761434 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab; Diphosphonates

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; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Chi Chiu Mok, MD, FRCP

  Tuen Mun Hospital

  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: Consultant

Study Record Dates

• First Submitted: October 30, 2011
• First Posted: November 7, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

CN (1)