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

NCT01495000 | Completed Phase 3 Results

• 1 other identifier: 114161
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Osteoporosis, Postmenopausal

Keywords

India; dual energy x-ray absorptiometry; bone mineral density; denosumab

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6

  Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) \* 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).

  Baseline and Month 6

Secondary Outcomes (17)

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

  Baseline and Month 6

• Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6

  Baseline; Months 1, 3, and 6

• Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)

  From Baseline up to Month 6

• Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6

  Baseline; Months 1, 3, and 6

• Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6

  Month 6

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: denosumab

Arm 2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

denosumab DRUG

60mg subcutaneous injection, single dose

Arm 1

placebo DRUG

placebo subcutaneous injection, single dose

Arm 2

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory Indian postmenopausal women with osteoporosis
• greater than 5 years postmenopausal
• aged 55 to 75 years old
• absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 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 or equal to -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 interferes with interpretation of study results
• 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
• any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results
• known to have tested positive for HIV

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Ahmedabad, 380015, India

Location

GSK Investigational Site

Bangalore, 560043, India

Location

GSK Investigational Site

Bangalore, 560052, India

Location

GSK Investigational Site

Bangalore, 560054, India

Location

GSK Investigational Site

Delhi, 110060, India

Location

GSK Investigational Site

Mangalore, 575002, India

Location

GSK Investigational Site

Nagpur, 440010, India

Location

GSK Investigational Site

Nagpur, 440012, India

Location

GSK Investigational Site

Pune, 411030, India

Location

GSK Investigational Site

Trivandrum, 695011, India

Location

GSK Investigational Site

Vadodra, 390007, India

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: December 15, 2011
• First Posted: December 19, 2011
• Study Start: January 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 7, 2014
• Results First Posted: December 25, 2013

Record last verified: 2013-12

Locations

IN (11)