A Study for Teriparatide in Severe Osteoporosis - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00696644

Purpose

This observational study will evaluate the proportion of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anti-osteoporotic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.

Condition	Intervention
Osteoporosis, Postmenopausal	Drug: Teriparatide

MedlinePlus related topics: Back Pain Fractures Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Proportion of severe osteoporotic fractures in the first 24 months from the initiation of anti-osteoporosis medication. Measures: Standard RX of the spine and RX of skeletal segment if any non vertebral fracture is suspected. [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment compliance, reason of discontinuation, BMD changes, changes in bone turnover marker and quality of life. Measures: Lumbar and femoral BMD, P1NP, questionnaires(EQ-5D,VAS and back pain) [ Time Frame: According to common clinical practice ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	650
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Postmenopausal women and men aged > 21 years old affected by severe osteoporosis	Drug: Teriparatide 20 mcg daily subcutaneous for 18 months.

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:

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incident 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 then 21 years
Investigator site personnel directly affiliated with the study or her/his family member

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696644

Contacts

Contact: There may be multiple sites in this observational study. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

Italy, Verona
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.	Recruiting
Valeggio sul Mincio, Verona, Italy, 36067
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12456, B3D-IT-B014
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00696644
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Musculoskeletal Diseases
Teriparatide
Fractures, Bone
Osteoporosis, Postmenopausal
Quality of Life

Osteoporosis
Bone Diseases, Metabolic
Pain
Bone Diseases
Back Pain

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009