The Effect of Teriparatide Compared with Risedronate on Back Pain in Postmenopausal Women with Osteoporotic Vertebral Fractures - GHCY

• Conditions: chronic back pain and osteoporotic vertebral fracture(s)

• Registration Number: EUCTR2005-005258-29-BE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 708

Inclusion Criteria

[1] Postmenopausal women 45 years of age and older at the time of entry into the trial, whose last menstrual period occurred at least 2 years prior to entry into the trial, and are sufficiently mobile to complete study visits. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum follicle stimulating hormone level >30 IU/L and serum estradiol level <20 pg/ml or <73 pmol/L.
[2] History of back pain, despite conservative analgesic treatment, with back pain that started at least 2 months prior to Visit 1, that is likely to be caused by osteoporotic vertebral fracture(s) in the opinion of the investigator.
[3] A minimum of one moderate osteoporotic vertebral fracture,
confirmed by the central reader, not caused by severe trauma that is
likely, in the opinion of the investigator, to be the cause of the back
pain:
• A moderate vertebral fracture is defined as at least a 25% decrease in anterior, central, or posterior vertebral height (T4 to L4) as compared to the average height of adjacent vertebrae.
• Osteoporotic fracture is defined as a fracture not caused by a wound or injury that is severe enough to cause a fracture in otherwise healthy persons.
• The initial fracture assessment performed by the investigator must be confirmed prior to randomization by the central reader prior to randomization. for determination of eligibility.
[4] Baseline pain score (mean score of the worst 24-hour pain intensity during the week prior to randomization) of at least 4.0 on the 11-point numeric rating scale.
[5] Lumbar spine and/or femoral neck and/or total hip BMD of 2.0 standard deviations or more below the average BMD for young, healthy, non-Hispanic, Caucasian women (T-score =-2.0). Table GHCY.1 presents the absolute values for assessing BMD at the lumbar spine and, femoral neck, and/or total hip. If a BMD measure is not available from the 6 months prior to enrollment, then baseline BMD
done prior to randomization must be performed locally, assessed by the investigator, and must meet the same BMD criteria as below.
[6] Able to read, understand, and respond to self-administered questionnaires.
[7] Without language barrier, cooperative, able to come to the clinic for all follow-up visits, and who has given informed consent before entering the study and after being informed of the medications and procedures to be used in this study.
[8] In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[9] Increased baseline risk of osteosarcoma; this includes patients with Paget’s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. As elevation of serum alkaline phosphatase activity may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme activity will also be exclusionary.
[10] Currently active or suspected diseases that affect bone metabolism, other than osteoporosis (such as renal osteodystrophy, osteomalacia, hyperparathyroidism, hypoparathyroidism, hyperthyroidism, sprue, inflammatory bowel disease, or malabsorption).
[11] Patients who are imminent candidates for kyphoplasty or vertebroplasty. Patients who require kyphoplasty or vertebroplasty after 6 months of treatment in this study will be allowed to continue in the study.
[12] Elevated serum calcium values, or abnormal serum thyroid-stimulating hormone, parathyroid hormone (PTH), or 25-hydroxyvitamin D levels, based on central laboratory reference ranges. Patients with minimal alterations of these labs may potentially be allowed in this study if there are no safety concerns, based on the opinion of both the investigator and the Lilly clinical research physician. Appropriate documentation of any such discussions is required.
[13] Clinical signs or symptoms, previous diagnostic imaging, lab test, or neurodiagnostic evidence of significant pathology which may be related to back pain and which would make interpretation of the back pain related to an osteoporotic vertebral fracture difficult or impossible, based on investigator assessment. Examples of such pathology would include (but are not limited to):
• radiculopathic/neuropathic pain due to nerve root compression of any cause
• significant spondylolisthesis, spinal stenosis, lateral recess stenosis
• spinal or paraspinal masses (such as tumors, metastases, angiomas, or abscesses)
• infectious or inflammatory processes of the spine or paraspinal region.
[14] Poor medical or psychiatric condition for participating in a clinical
study, in the opinion of the investigator.
[15] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator.
[16] History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. Patients with multiple myeloma or metastases to bone are excluded
[17] Active liver disease or clinical jaundice. Significantly impaired hepatic function, defined as ALT>75 U/L or GGT >300U/L.
[18] Significantly impaired renal function as defined by the following criteria:
• Significantly impaired renal function as defined as serum creatinine >2.0 mg/dL or 176.8 mmol/L.
[19] Patients with a history of nephrolithiasis or urolithiasis within 2 years prior to Visit 2.
[20] Patients with known contraindications to risedronate therapy or active or recent history of significant upper gastrointestinal disorders.
[21] Treatment with:
• oral strontium ranelate for any duration
• fluoride at therapeutic doses (=20 mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to Visit 2 (previous or current use of fluoridated water or topical dental fluoride t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified