Postmenopausal Osteoporosis
Conditions
Keywords
Osteoporosis., Osteoporosis-Postmenopausal., Bone Diseases-Metabolic., Bone Diseases., Musculoskeletal Diseases.
Brief summary
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
Interventions
DRUGRomosozumab
Administered by subcutaneous injection once a month (QM)
DRUGPlacebo
Administered by subcutaneous injections once a month
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment. * Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening. * BMD T-score \</= -2.50 at the lumbar spine, total hip or femoral neck. * At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA. * Other inclusion criteria may apply.
Exclusion criteria
* Subjects with a BMD T-score \</= -4.0 at the lumbar spine, total hip, or femoral neck. * History of hip fracture. * Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities. * Known sensitivity or intolerance calcium and vitamin D products. * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine | Baseline and month 6 | Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | Baseline and month 6 | Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. |
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | Baseline and month 6 | Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at 10 centers in South Korea. Participants were enrolled from 16 January 2017 to 17 August 2017.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive either romosozumab 210 mg subcutaneously (SC) QM or matched placebo SC QM. Upon completion of the 6-month treatment period, participants were followed for an additional 3 months.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo subcutaneous injection once a month for 6 months. | 33 |
| Romosozumab 210 mg Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. | 34 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Romosozumab 210 mg | Total |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 7.2 | 66.7 years STANDARD_DEVIATION 7.6 | 67.5 years STANDARD_DEVIATION 7.4 |
| Age, Customized ≥ 65 to < 75 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Customized < 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Customized ≥ 75 years | 7 Participants | 4 Participants | 11 Participants |
| Femoral Neck BMD T-score | -2.5309 T-score STANDARD_DEVIATION 0.5395 | -2.4494 T-score STANDARD_DEVIATION 0.6069 | -2.4896 T-score STANDARD_DEVIATION 0.5718 |
| Lumbar Spine Bone Mineral Density (BMD) T-score | -2.6483 T-score STANDARD_DEVIATION 0.645 | -2.6622 T-score STANDARD_DEVIATION 0.8155 | -2.6554 T-score STANDARD_DEVIATION 0.731 |
| Race/Ethnicity, Customized Asian | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total Hip BMD T-score | -2.1797 T-score STANDARD_DEVIATION 0.6243 | -2.1515 T-score STANDARD_DEVIATION 0.7114 | -2.1654 T-score STANDARD_DEVIATION 0.665 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 34 |
| other Total, other adverse events | 4 / 33 | 2 / 34 |
| serious Total, serious adverse events | 2 / 33 | 0 / 34 |
Outcome results
Primary
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the lumbar spine.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine | -0.1 percent change | Standard Error 0.8 |
| Romosozumab 210 mg | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine | 9.5 percent change | Standard Error 0.9 |
p-value: <0.00195% CI: [7.6, 11.5]ANCOVA
Secondary
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the femoral neck.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | 0.8 percent change | Standard Error 0.7 |
| Romosozumab 210 mg | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | 3.0 percent change | Standard Error 0.6 |
p-value: 0.00495% CI: [0.7, 3.6]ANCOVA
Secondary
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the total hip.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | 0.3 percent change | Standard Error 0.4 |
| Romosozumab 210 mg | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | 2.9 percent change | Standard Error 0.5 |
p-value: <0.00195% CI: [1.4, 3.7]ANCOVA