A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

NCT01457950 | Completed Phase 3 Results

• 1 other identifier: 114163
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

Conditions

Osteoporosis, Postmenopausal

Keywords

denosumab; Republic of Korea; dual energy x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6

  Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.

  Baseline and Month 6

Secondary Outcomes (17)

• Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1

  Baseline and Month 1

• Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6

  Baseline, Month 1 and Month 6

• Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6

  Baseline, Months 1, 3 and 6

• Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)

  From Baseline up to Month 6

• Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6

  Baseline and Month 6

Other Outcomes (19)

• Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab

  Baseline and Month 12

• Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo

  Month 6 and Month 12

• Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab

  Baseline and Month 12

Study Arms (3)

Arm 1

EXPERIMENTAL

denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase

Drug: denosumab

Arm 2

PLACEBO COMPARATOR

placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase

Drug: placebo

Arm 3

EXPERIMENTAL

open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase

Drug: open-label denosumab

Interventions

denosumab DRUG

double-blind phase: 60mg subcutaneous injection, single dose

Arm 1

placebo DRUG

double-blind phase: placebo subcutaneous injection, single dose

Arm 2

open-label denosumab DRUG

open-label phase: 60mg subcutaneous injection, single dose

Arm 3

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory Korean postmenopausal women with osteoporosis
• greater than 5 years postmenopausal
• aged 60 to 90 years old
• absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.

You may not qualify if:

• previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
• current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
• rheumatoid arthritis
• cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
• medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
• medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
• malignancy within 5 years except certain resected types
• malabsorption syndrome or gastrointestinal disorders associated with malabsorption
• abnormal calcium level
• vitamin D deficiency
• any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results
• severe renal impairment or on dialysis
• impaired immune system or subject is taking immunosuppressants
• oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery
• any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Busan, 602-739, South Korea

Location

GSK Investigational Site

Daegu, South Korea

Location

GSK Investigational Site

Gwangju, 501-757, South Korea

Location

GSK Investigational Site

Seoul, 100-380, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Songpa-gu, Seoul, 138-736, South Korea

Location

GSK Investigational Site

Suwon, 443-721, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; 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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 7, 2014
• Results First Posted: October 29, 2013

Record last verified: 2014-02

Locations

KR (10)