Clinical trial NCT00696644: A Study for Teriparatide in Severe Osteoporosis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 794
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

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 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

Primary outcomes:
measure: Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
timeFrame: From 0 to 24 months
Secondary outcomes:
measure: Treatment compliance
timeFrame: From 0 to 24 months
measure: Reason of discontinuation
timeFrame: From 0 to 24 months
measure: BMD changes (lumbar and femoral BMD)
timeFrame: From 0 to 24 months
measure: Changes in bone turnover marker measured by P1NP
timeFrame: From 0 to 24 months
measure: Quality of Life (measured by EQ-5D of EuroQol Group)
timeFrame: From 0 to 24 months
measure: Back Pain measured by visual analogue scale and back pain questionnaire
timeFrame: From 0 to 24 months
measure: Assessment of motor performance and chair rising test
timeFrame: From 0 to 24 months
Other outcomes:
Locations:
city: Valeggio sul Mincio
country: Italy
facility: 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.
state: Verona
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: