Osteoporosis, PostmenopausalPhase 3NCT01457950
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
A Phase 3 study testing denosumab and open-label denosumab in people with Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 10 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- denosumab and open-label denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Nov 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
GSK Investigational Site
Busan, 602-739
GSK Investigational Site
Daegu
GSK Investigational Site
Gwangju, 501-757
GSK Investigational Site
Seoul, 100-380
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Songpa-gu, Seoul, 138-736
GSK Investigational Site
Suwon, 443-721
About this study
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
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
- Being tested
- denosumab, placebo, open-label denosumab
- Keywords
- denosumab, Republic of Korea, dual energy x-ray absorptiometry
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denosumabDrug
double-blind phase: 60mg subcutaneous injection, single dose
placeboDrug
double-blind phase: placebo subcutaneous injection, single dose
open-label denosumabDrug
open-label phase: 60mg subcutaneous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase Receives: Drug: denosumab |
| Arm 2 | Placebo comparator | placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase Receives: 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 Receives: Drug: open-label denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 6
Secondary outcomes (17)
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
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 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 1 - measure at Baseline) divided by the measure at Baseline * 100.
Measured: Baseline and Month 1
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (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 1/6 - measure at Baseline) divided by the measure at Baseline * 100.
Measured: Baseline, Month 1 and Month 6
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
Measured: Baseline, Months 1, 3 and 6
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Measured: From Baseline up to Month 6
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: 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
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Hematocrit at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Mean Corpuscular Volume at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Red Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Red Cell Distribution Width at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457950
- Sponsor's protocol ID
- 114163
- Status last verified
- Feb 2014
- First submitted
- 20 Oct 2011
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01457950
- Acronym / sponsor ID
- 114163
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- denosumab, Republic of Korea, dual energy x-ray absorptiometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Posted 29 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: denosumabdenosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase |
| Arm 2 | Placebo comparator | Drug: placeboplacebo subcutaneous injection, single dose at the start of the 6-month double-blind phase |
| Arm 3 | Experimental | Drug: open-label denosumabopen-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denosumabdouble-blind phase: 60mg subcutaneous injection, single dose | Drug | Arm 1 |
| placebodouble-blind phase: placebo subcutaneous injection, single dose | Drug | Arm 2 |
| open-label denosumabopen-label phase: 60mg subcutaneous injection, single dose | Drug | Arm 3 |
Primary outcome
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time frame: Baseline and 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.
17 secondary outcomes
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Time frame: Baseline and Month 1
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Time frame: Baseline, Month 1 and Month 6
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
Time frame: Baseline, Months 1, 3 and 6
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
Time frame: From Baseline up to Month 6
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Time frame: 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
Time frame: Baseline and Month 6
Change From Baseline in Hematocrit at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Mean Corpuscular Volume at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Red Blood Cell Count at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Red Cell Distribution Width at Month 6
Time frame: Baseline and Month 6
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Time frame: Baseline and Month 6
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denosumab and open-label denosumab in people with Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.