A Study for Teriparatide in Severe Osteoporosis (ISSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696644
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : May 9, 2011
Information provided by:
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Osteoporosis 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
Actual Enrollment : 794 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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.

Primary Outcome Measures :
  1. Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. [ Time Frame: From 0 to 24 months ]

Secondary Outcome Measures :
  1. Treatment compliance [ Time Frame: From 0 to 24 months ]
  2. Reason of discontinuation [ Time Frame: From 0 to 24 months ]
  3. BMD changes (lumbar and femoral BMD) [ Time Frame: From 0 to 24 months ]
  4. Changes in bone turnover marker measured by P1NP [ Time Frame: From 0 to 24 months ]
  5. Quality of Life (measured by EQ-5D of EuroQol Group) [ Time Frame: From 0 to 24 months ]
  6. Back Pain measured by visual analogue scale and back pain questionnaire [ Time Frame: From 0 to 24 months ]
  7. Assessment of motor performance and chair rising test [ Time Frame: From 0 to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696644

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
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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00696644     History of Changes
Other Study ID Numbers: 12456
B3D-IT-B014 ( Other Identifier: Eli Lilly and Company )
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011

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