Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in postmenopausal women with osteoporosis that have back pain due to a spinal bone fracture.

Official Title

The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

Conditions

Postmenopausal Osteoporosis, Back Pain, Spinal Fracture

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Proportion of patients treated with daily teriparatide compared with weekly risedronate who have at least a 30% improvement in the 11-point numeric rating scale evaluating back pain from baseline to Month 6.

Secondary Outcome Measures:

• Proportion of patients treated with at least a 30% reduction in the severity of worst back pain will be assessed using the mean score from the 11-point numeric rating scale from baseline to 12 and 18 months
• Proportion of patients treated with at least a 30% reduction in the severity of average back pain will be assessed using the mean score from the 11-point numeric rating scale from baseline to 6, 12, and 18 months
• Time to first occurrence of the proportion of patients treated with at least a 30% reduction for both worst and average back pain will be assessed using the mean score from the 11-point numeric rating scale from baseline to 6, 12, and 18 months
• The measure for the effect on daily living activities as assessed by the Roland Disability Questionnaire will be the mean change in Roland score from baseline to 3, 6, 12, and 18 months
• The measure on quality of life as assessed by QUALEFFO will be the mean change is score from baseline to 6, 12, and 18 months

Study Start

June 2006; Expected completion: December 2009

Eligibility & Criteria

• Ages Eligible for Study: 45 Years and above
• Genders Eligible for Study: Female

Inclusion Criteria:

• Postmenopausal women 45 years or older. No period for at least two years.
• History of back pain (likely due to spinal bone fracture determined by investigator).
• Minimum of one moderate spinal bone fracture.
• Beginning pain level of at least four on an eleven point scale.
• Bone Mineral Density (BMD) must meet criteria
• Able to read, understand, and administer self-questionnaires.
• Be willing and able to use a pen-injector to deliver the medication.

Exclusion Criteria:

• Are at increased risk for osteosarcoma.
• Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
• Patients that already know that they will require procedures to repair their spinal bone fractures.
• Abnormal values of certain lab tests.
• Anything that would make it difficult to determine if the back pain was due to the fracture.
• Poor medical or psychiatric condition.
• Alcohol or drug abuse within a year of the study start.

Total Enrolment

546

Contact Details

Australian Locations:

• Malvern East, 3145, Australia; Recruiting
• Kogarah, New South Wales, 2217, Australia; Recruiting
• Randwick, Sydney, New South Wales, 2031, Australia; Recruiting
• Maroochydore, Queensland, 4558, Australia; Not yet recruiting
• Keswick, South Australia, 5035, Australia; Recruiting

For more information, refer to Lilly Clinical Trials