Last updated: 11/07/2018 07:24:17
A Study in Korean Postmenopausal Women with Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study with a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women with Osteoporosis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean percent change from Baseline in lumbar spine BMD at Month 6
Timeframe: Baseline and Month 6
Secondary outcomes:
Mean percent change from Baseline in lumbar spine BMD at Month 1
Timeframe: Baseline and Month 1
Mean percent change from Baseline in total hip, femoral neck, and trochanter BMD at Month 1 and Month 6
Timeframe: Baseline, Month 1 and Month 6
Median percent change from Baseline in s-CTX and s-P1NP biomarkers at Months 1, 3 and 6
Timeframe: Baseline, Months 1, 3 and 6
Number of participants with any adverse events (AE) or any serious adverse events (SAE)
Timeframe: From Baseline up to Month 6
Change from Baseline in albumin/globulin ratio and blood urea nitrogen (BUN)/creatinine ratio at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in albumin, hemoglobin, mean corpuscle hemoglobin and total protein at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in alkaline phosphatase, alanine amino transferase, creatinine kinase, gamma glutamyl transferase and lactate dehydrogenase at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, platelet count and white blood cell count at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in direct bilirubin, indirect bilirubin, total bilirubin, creatinine and uric acid at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglycerides, urea/BUN, very low density lipoproteins (VLDL) cholesterol calculation at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in hematocrit at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in mean corpuscle hemoglobin at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in mean corpuscular volume at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in red blood cell count at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in red cell distribution width at Month 6
Timeframe: Baseline and Month 6
Number of participants with a change from Baseline in vital signs of potential clinical concern at Month 6
Timeframe: Baseline and Month 6
Number of participants with positive and negative results for anti-body formation to denosumab
Timeframe: Month 6
Interventions:
Drug: denosumab
Drug: placebo
Drug: open-label denosumab
Enrollment:
135
Observational study model:
Not applicable
Primary completion date:
2012-28-12
Time perspective:
Not applicable
Clinical publications:
Jung-Min Koh, Dong Jin Chung, Yoon-Sok Chung, Moo-Il Kang, In-Ju Kim, Yong-Ki Min, Han-Jin Oh, Il Hyung Park, Yil-Seob Lee, Barbara Kravitz, Brian Waterhouse, Antonio Nino, Lorraine A. Fitzpatrick . Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension. Yonsei Med J. 2016;57(4):905-914.
Yoon-Sok Chung,Dong Jin Chung, Moo-Il Kang, In-Ju Kim,Jung-Min Koh, Yong-Ki Min, Han-Jin Oh, Il Hyung Park, Yil-Seob Lee, Barbara Kravitz, Brian Waterhouse, Lorraine Fitzpatrick, Antonio Nino. Vitamin D Repletion in Korean Postmenopausal Women with Osteoporosis. Yonsei Med J. 2016;57(4):923-927.
Medical condition
Osteoporosis, Postmenopausal
Product
denosumab
Collaborators
Not applicable
Study date(s)
November 2011 to July 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
60 - 90 years
Accepts healthy volunteers
No
- Ambulatory Korean postmenopausal women with osteoporosis
- greater than 5 years postmenopausal
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
- 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
- less than two lumbar vertebrae evaluable for DXA measurements
- height, weight, or girth that may preclude accurate DXA measurements
- drug or alcohol abuse within 12 months that interferes with understanding or completing the study
- known sensitivity to mammalian cell-derived drug products
- use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)
Trial location(s)
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-28-12
Actual study completion date
2013-04-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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