Denosumab China Phase III Study

NCT02014467 | Completed Phase 3 Results

• 1 other identifier: 114165
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 8

Brief Summary

This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12

  Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.

  Baseline and Month 12

Secondary Outcomes (27)

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

  Baseline and Month 6

• Percent Change From Baseline in BMD at the Total Hip at Month 6

  Baseline and Month 6

• Percent Change From Baseline in BMD at the Femoral Neck at Month 6

  Baseline and Month 6

• Percent Change From Baseline in BMD at the Trochanter at Month 6

  Baseline and Month 6

• Percent Change From Baseline in BMD at the Total Hip at Month 12

  Baseline and Month 12

Study Arms (2)

Denosumab 60mg

EXPERIMENTAL

injection

Drug: Denosumab; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

injection

Drug: Placebo; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D

Interventions

Denosumab DRUG

Injection

Denosumab 60mg

Placebo DRUG

Injection

Placebo

Elemental Calcium DIETARY_SUPPLEMENT

Oral, at least 600 mg

Denosumab 60mg; Placebo

Vitamin D DIETARY_SUPPLEMENT

Oral, at least 400 IU

Denosumab 60mg; Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to provide written informed consent.
• Of Chinese origin - defined as being born in China, having four ethnic Chinese grandparents.
• Ambulatory woman between the age of 60 and 90 years, inclusive.
• The subject has a BMD absolute value consistent with a T-score\<-2.5 and \>-4.0 at either the lumbar spine or total hip.
• All subjects must have at least one of following additional the risk factors:
• history of fracture parental history of hip fracture increased bone turnover rate at screening (s-CTX \>1.0 SD above the mean in healthy premenopausal women) low body weight (BMI≤19kg/m2) elderly (age≥70y) current smoker
• Postmenopausal defined as \>5 years postmenopausal, which can be \>5 years of spontaneous amenorrhea or \>5 years post surgical bilateral oophorectomy. Use follicle stimulating hormone (FSH) levels \>40 mIU/mL to confirm surgical postmenopausal status, where bilateral oophorectomy status is uncertain.

You may not qualify if:

• Bone/metabolic disease:
• Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings.
• Paget's disease Cushing's disease Hyperprolactinemia
• Current hyperparathyroidism or hypoparathyroidism by medical record
• Thyroid condition: Hyperthyroidism or hypothyroidism. Only subjects with hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed per the following criteria:
• If TSH level is below normal range, subject is not eligible for the study. If TSH level is elevated (\>5.5 μIU/mL and ≤10.0 μIU/mL), serum T4 should be measured.
• If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study. If TSH level is \> 10.0 μIU/mL, subject is not eligible.
• Rheumatoid arthritis
• Malignancy:
• Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5years.
• Malabsorption syndrome: malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example Crohn's Disease and chronic pancreatitis.
• Renal disease - severe renal impairment
• Liver disease:
• Cirrhosis of the liver Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if the subject otherwise meets study entry criteria (e.g., presence of hepatitis B surface antigen or positive Hepatitis C test result within 3 months of Screening).
• Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610072, China

Location

GSK Investigational Site

Beijing, 100035, China

Location

GSK Investigational Site

Beijing, 100050, China

Location

GSK Investigational Site

Beijing, 100730, China

Location

GSK Investigational Site

Chengdu, 610083, China

Location

GSK Investigational Site

Shanghai, 200040, China

Location

GSK Investigational Site

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab; Calcium; Vitamin D

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; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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 12, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-09

Locations

CN (8)