Osteoporosis, PostmenopausalPhase 3NCT01495000
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
A Phase 3 study testing denosumab in people with Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 11 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 11 sitesIndia
- Study dates
- Jan 2012to Feb 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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 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
- 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
11 sites in 1 country.
11 sites in 1 country
India11 sites
GSK Investigational Site
Ahmedabad, 380015
GSK Investigational Site
Bangalore, 560043
GSK Investigational Site
Bangalore, 560052
GSK Investigational Site
Bangalore, 560054
GSK Investigational Site
Delhi, 110060
GSK Investigational Site
Mangalore, 575002
GSK Investigational Site
Nagpur, 440010
GSK Investigational Site
Nagpur, 440012
GSK Investigational Site
Pune, 411030
GSK Investigational Site
Trivandrum, 695011
GSK Investigational Site
Vadodra, 390007
About this study
Official title: A Six-Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Indian 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 Indian postmenopausal women with osteoporosis.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- denosumab, placebo
- Keywords
- India, dual energy x-ray absorptiometry, bone mineral density, denosumab
- 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
60mg subcutaneous injection, single dose
placeboDrug
placebo 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 treatment Receives: Drug: denosumab |
| Arm 2 | Placebo comparator | placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
BMD at the total hip, femoral neck, and trochanter was measured by the 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 ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).
Measured: 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
Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.
Measured: Baseline; Months 1, 3, and 6
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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 with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Measured: 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
Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as "low." If the change from Baseline is an increase greater than the threshold, it is categorized ad "high."
Measured: Baseline; Months 1, 3, and 6
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6
The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.
Measured: Month 6
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. 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 Concentration (Conc.), and Total Protein at Month 6
Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. 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, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6
Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. 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, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6
Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. 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
Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. 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, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Hematocrit at Month 6
Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Blood samples were collected for the measurement of hemoglobin values. 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
Blood samples were collected for the measurement of mean corpuscular volume values. 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
Blood samples were collected for the measurement of red blood cell count values. 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
Blood samples were collected for the measurement of red cell distribution width values. 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 at Month 6
The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are 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 posted19 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 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
- 250 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
- NCT01495000
- Sponsor's protocol ID
- 114161
- Status last verified
- Dec 2013
- First submitted
- 15 Dec 2011
- Last updated
- 7 Feb 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 Feb 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 to Evaluate the Efficacy and Safety of Denosumab in Indian Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT01495000
- Acronym / sponsor ID
- 114161
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- India, dual energy x-ray absorptiometry, bone mineral density, denosumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Posted 25 Dec 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 Indian postmenopausal women with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: denosumabdenosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
| Arm 2 | Placebo comparator | Drug: placeboplacebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 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 |
|---|---|---|
| denosumab60mg subcutaneous injection, single dose | Drug | Arm 1 |
| placeboplacebo subcutaneous injection, single dose | Drug | Arm 2 |
Primary outcome
Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6
Time frame: Baseline and 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).
17 secondary outcomes
Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6
Time frame: 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
Time frame: Baseline; Months 1, 3, and 6
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Time frame: 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
Time frame: Baseline; Months 1, 3, and 6
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6
Time frame: 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 Concentration (Conc.), and Total Protein at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate 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, Total Neutrophils, Platelet Count, and White Blood Cell Count 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, and 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 Positive and Negative Results for Anti-body Formation to Denosumab at Month 6
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 Feb 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
11 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 in people with Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 11 sites in India.
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 20 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. 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 25 Dec 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 Bone Mineral Density at the Lumbar Spine 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 Feb 2014.