Osteoporosis
Conditions
Brief summary
The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.
Interventions
DRUGplacebo
oral tablet once a month for 12 months
DRUGrisedronate
tablet, 150 mg once a month for 12 months
Sponsors
Sanofi
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 57 Years
Healthy volunteers
No
Inclusion criteria
* Female: 40 and 57 years of age inclusive * cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment * have osteopenia defines as having the following: have osteopenia defined as having the following: * Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR * Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5; * have a body mass index (BMI) between 18 and 30 kg/m2.
Exclusion criteria
* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia * use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone * hypocalcemia or hypercalcemia of any cause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius | 12 months | The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erosion Index of the Distal Radius | 6 months | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. |
Countries
Argentina, United States
Participant flow
Recruitment details
Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.
Pre-assignment details
The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.
Participants by arm
| Arm | Count |
|---|---|
| One 150 mg Risedronate Once a Month one 150 mg risedronate once a month, orally | 7 |
| Placebo Tablet Once a Month Placebo tablet once a month, orally | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study was terminated early by Sponsor | 7 | 6 |
Baseline characteristics
| Characteristic | One 150 mg Risedronate Once a Month | Placebo Tablet Once a Month | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age Continuous | 51.42 years STANDARD_DEVIATION 2.5 | 53.83 years STANDARD_DEVIATION 2.63 | 52.53 years STANDARD_DEVIATION 2.75 |
| Region of Enrollment Argentina | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 7 | 2 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius
The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.
Time frame: 12 months
Population: Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Secondary
Erosion Index of the Distal Radius
Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Time frame: 6 months
Population: Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.