A Study for Teriparatide in Severe Osteoporosis

Study Overview
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Brief Summary
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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
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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: at least 3 severe vertebral fractures 2 severe vertebral fractures and 1 hip fracture an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.

Official Title
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An Italian Observational Study to Evaluate Fracture Outcomes, Compliance to Treatment, Back Pain, Health-related Quality of Life in Patients With Severe Osteoporosis Treated According to Common Clinical Practice

Conditions
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Osteoporosis, Postmenopausal, Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with severe osteoporosis<br>Postmenopausal women and men aged > 21 years old affected by severe osteoporosis | Drug: Teriparatide<br>* 20 mcg daily subcutaneous for 18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. |  | From 0 to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment compliance |  | From 0 to 24 months | 
| 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 | 
| Quality of Life (measured by EQ-5D of EuroQol Group) |  | 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 |