A Study for Teriparatide in Severe Osteoporosis (ISSO)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00696644
First received: June 11, 2008
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Osteoporosis, Postmenopausal
Osteoporosis
Drug: Teriparatide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment compliance [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • Reason of discontinuation [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • BMD changes (lumbar and femoral BMD) [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • Changes in bone turnover marker measured by P1NP [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • Quality of Life (measured by EQ-5D of EuroQol Group) [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • Back Pain measured by visual analogue scale and back pain questionnaire [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
  • Assessment of motor performance and chair rising test [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]

Enrollment: 794
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, Italy, 36067
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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00696644     History of Changes
Other Study ID Numbers: 12456, B3D-IT-B014
Study First Received: June 11, 2008
Last Updated: May 5, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014