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

June 11, 2008
May 5, 2011
June 2008
April 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00696644 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
A Study for Teriparatide in Severe Osteoporosis
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

  • Osteoporosis, Postmenopausal
  • Osteoporosis
Drug: Teriparatide
20 mcg daily subcutaneous for 18 months.
Patients with severe osteoporosis
Postmenopausal women and men aged > 21 years old affected by severe osteoporosis
Intervention: Drug: Teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
794
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00696644
12456, B3D-IT-B014
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP