A Study for Teriparatide in Severe Osteoporosis (ISSO)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Teriparatide

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.

• Study Type: Observational
• Enrollment (Actual): 794

Contacts and Locations

Study Locations

• Italy
  • Verona
    • Valeggio sul Mincio, Verona, Italy, 36067
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe osteoporosis; Postmenopausal women and men aged > 21 years old affected by severe osteoporosis	Drug: Teriparatide; 20 mcg daily subcutaneous for 18 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (ESTIMATE): June 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 9, 2011
• Last Update Submitted That Met QC Criteria: May 5, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: 12456; B3D-IT-B014 (OTHER: Eli Lilly and Company)