Osteoporosis, Osteoporosis, Postmenopausal
Conditions
Brief summary
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
Detailed description
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have: 1. at least 3 severe vertebral fractures 2. 2 severe vertebral fractures and 1 hip fracture 3. an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
Interventions
DRUGTeriparatide
20 mcg daily subcutaneous for 18 months.
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incidental vertebral or hip fracture during treatment with an antiresorptive, or having 3 or more severe vertebral fractures or having 2 severe vertebral fractures and an historical hip fracture.
Exclusion criteria
* Any contraindication for the use of antiosteoporotic drug * Premenopausal women or men younger than 21 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. | From 0 to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Reason of discontinuation | From 0 to 24 months |
| BMD changes (lumbar and femoral BMD) | From 0 to 24 months |
| Changes in bone turnover marker measured by P1NP | From 0 to 24 months |
| Treatment compliance | From 0 to 24 months |
| Back Pain measured by visual analogue scale and back pain questionnaire | From 0 to 24 months |
| Assessment of motor performance and chair rising test | From 0 to 24 months |
| Quality of Life (measured by EQ-5D of EuroQol Group) | From 0 to 24 months |
Countries
Italy
Outcome results
None listed