A Study for Teriparatide in Severe Osteoporosis

Osteoporosis Clinical Trial

— ISSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696644
• Other study ID #: 12456
• Secondary ID: B3D-IT-B014
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: May 5, 2011
• Start date: June 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 794
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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

Locations

Country	Name	City	State
Italy	For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valeggio sul Mincio	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.		From 0 to 24 months	No
Secondary	Treatment compliance		From 0 to 24 months	No
Secondary	Reason of discontinuation		From 0 to 24 months	No
Secondary	BMD changes (lumbar and femoral BMD)		From 0 to 24 months	No
Secondary	Changes in bone turnover marker measured by P1NP		From 0 to 24 months	No
Secondary	Quality of Life (measured by EQ-5D of EuroQol Group)		From 0 to 24 months	No
Secondary	Back Pain measured by visual analogue scale and back pain questionnaire		From 0 to 24 months	No
Secondary	Assessment of motor performance and chair rising test		From 0 to 24 months	No

External Links

•   Lilly Clinical Trial Registry