A Study for Teriparatide in Severe Osteoporosis

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2011

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

  • Drug: Teriparatide
    • 20 mcg daily subcutaneous for 18 months.

Arms, Groups and Cohorts

  • Patients with severe osteoporosis
    • Postmenopausal women and men aged > 21 years old affected by severe osteoporosis

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
    • Time Frame: From 0 to 24 months

Secondary Measures

  • Treatment compliance
    • Time Frame: From 0 to 24 months
  • Reason of discontinuation
    • Time Frame: From 0 to 24 months
  • BMD changes (lumbar and femoral BMD)
    • Time Frame: From 0 to 24 months
  • Changes in bone turnover marker measured by P1NP
    • Time Frame: From 0 to 24 months
  • Quality of Life (measured by EQ-5D of EuroQol Group)
    • Time Frame: From 0 to 24 months
  • Back Pain measured by visual analogue scale and back pain questionnaire
    • Time Frame: From 0 to 24 months
  • Assessment of motor performance and chair rising test
    • Time Frame: From 0 to 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Chief Medical Officer, Eli Lilly
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company

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