Osteoporosis
Conditions
Keywords
Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates
Brief summary
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Detailed description
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Interventions
DRUGAlendronate
70 mg per week
DRUGPlacebo
1 pill per week
Sponsors
German Federal Ministry of Education and Research
Evangelisches Krankenhaus Lutherhaus gGmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women or men \> 60 years * DXA T-Score at lumbar spine, total hip or femur neck \<-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy * Pretreatment with bisphosphonates for at least four years * Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009 * Signed informed consent
Exclusion criteria
* Other pharmacological treatment of osteoporosis during the last 48 months * Other bone diseases * Malabsorption syndromes * Renal insufficiency with a calculated creatinine clearance \< 35 ml/min * Diseases of the esophagus, delayed esophageal clearance * UUnability to realise the intake instructions * Hypocalcemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Osteoporotic Fractures | From baseline to study termination (mean duration 5.6 months) | Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From baseline to study termination (mean duration 5.6 months) | Number of deaths |
| Combination of New Osteoporotic Fractures and Deaths | From baseline to study termination (mean duration 5.6 months) | Number of participants with a new osteoporotic fracture or death |
Countries
Germany
Participant flow
Recruitment details
The study was early terminated due to a low recruitment rate
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo, administered orally once weekly | 221 |
| Alendronate Alendronate 70 mg, administered orally once weekly | 215 |
| Total | 436 |
Baseline characteristics
| Characteristic | Placebo | Alendronate | Total |
|---|---|---|---|
| Age, Continuous | 75.3 Years STANDARD_DEVIATION 6.9 | 74.3 Years STANDARD_DEVIATION 7.1 | 74.8 Years STANDARD_DEVIATION 7 |
| Region of Enrollment Germany | 221 Participants | 215 Participants | 436 Participants |
| Sex: Female, Male Female | 194 Participants | 203 Participants | 397 Participants |
| Sex: Female, Male Male | 27 Participants | 12 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 113 / 197 | 94 / 188 |
| serious Total, serious adverse events | 38 / 197 | 31 / 188 |
Outcome results
Primary
Number of New Osteoporotic Fractures
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Time frame: From baseline to study termination (mean duration 5.6 months)
Population: Full Analysis Set (all randomized participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of New Osteoporotic Fractures | 5 osteoporotic fractures |
| Alendronate | Number of New Osteoporotic Fractures | 5 osteoporotic fractures |
Secondary
Combination of New Osteoporotic Fractures and Deaths
Number of participants with a new osteoporotic fracture or death
Time frame: From baseline to study termination (mean duration 5.6 months)
Population: Full Analysis Set (all randomized participants)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Combination of New Osteoporotic Fractures and Deaths | 7 Participants |
| Alendronate | Combination of New Osteoporotic Fractures and Deaths | 5 Participants |
Secondary
Mortality
Number of deaths
Time frame: From baseline to study termination (mean duration 5.6 months)
Population: Full Analysis Set (all randomized participants)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Mortality | 2 Participants |
| Alendronate | Mortality | 0 Participants |