NCT00696644

A Study for Teriparatide in Severe Osteoporosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 794 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis, Postmenopausal
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Teriparatide	20 mcg daily subcutaneous for 18 months.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-06-13
• Last updated: 2011-05-09

Locations

1 site across 1 country: Italy