A study in postmenopausal women with severe osteoporosis to compare the effects of two osteoporosis drugs (Teriparatide and Risedronate) on fractures of the spine

• Conditions: Postmenopausal women with established osteoporosis and at least two moderate or one severe prevalent fragility fracture.; MedDRA version: 16.0Level: LLTClassification code 10031288Term: Osteoporosis with fractureSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-000123-41-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1340

Inclusion Criteria

[1] Postmenopausal women = 45 years of age 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 < 55 years of age in whom a bilateral oophorectomy cannot clearly be documented must
have their postmenopausal status confirmed by a serum FSH level > 40 IU/L and serum estradiol level < 20 pg/mL or < 73 pmol/L.
[2] A minimum of 2 moderate (SQ2) or 1 severe (SQ3) vertebral fragility fractures, confirmed by the central reader.
[3] AP lumbar spine or total hip or femoral neck BMD = 1.5 SD below the average BMD for young healthy, non-Hispanic, Caucasian women (T-score = –1.5 SD). Absolute BMD values will be applied to determine patient eligibility.
[4] Without language barrier, cooperative, able to come to the clinic for all follow-up visits; has given informed consent before entering the study and after being informed of the medications and procedures to be used in this study.
[5] In the opinion of the investigator, is willing to be trained and to 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 caregiver 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

[6] 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.
[7] History of unresolved skeletal diseases that affect bone metabolism, other than osteoporosis, including renal osteodystrophy, osteomalacia, hyperparathyroidism
(uncorrected), hypoparathyroidism, and intestinal
malabsorption.
[8] Abnormally elevated values of serum albumin-corrected calcium levels at baseline, defined as = 10.6 mg/dL (or = 2.65 mmol/L). In cases with borderline non-eligible values (= 10.6 and = 10.7 mg/dL), a re-test would be allowed during the screening period.
[9] Abnormally low values of serum albumin- corrected calcium levels at baseline, defined as < 8.0 mg/dL (or < 2.0 mmol/L). In cases with borderline non-eligible values (> 7.8 to < 8.0 mg/dL), a re-test would be allowed during the screening period to allow normalization with vitamin D and calcium supplements before the randomization visit.
[10] Abnormally elevated values of serum intact PTH(1-84) at baseline defined as > 72 pg/mL (or > 7.6 pmol/L).
[11] Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin D levels < 9.2 ng/mL (or < 23 nmol/L). In cases with borderline non-eligible values (> 8.0 and < 9.2 ng/mL), a re-test would be allowed during the screening period to allow normalization with vitamin D supplement before the randomization visit.
[12] Abnormal thyroid function not corrected by therapy. Patients with subclinical hyperthyroidism or hypothyroidism, defined as abnormally low or high TSH values respectively, with normal fT4 values are eligible to participate in the study.
[13] 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. Patients 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.
[14] Active liver disease or clinical jaundice. Significantly impaired hepatic function, defined as AST > 75 U/L or ALT > 75 U/L or GGT > 300 U/L.
[15] Significantly impaired renal function as defined by a calculated endogenous creatinine clearance (ClCr) < 30 mL/min using the following Cockcroft-Gault formula for ClCr.
[16] History of nephrolithiasis or urolithiasis within 1 year prior to Visit 2.
[17] Considered imminent candidates for kyphoplasty or vertebroplasty before Visit 2.
[18] Patients who have been treated with kyphoplasty or vertebroplasty at 3 or more levels before Visit 2, regardless of the time since the last procedure.
[19] Patients who have been treated with kyphoplasty or vertebroplasty within the last 6 months before Visit 2.
[20] Patients with history of osteonecrosis of the jaw or who are, according to the clinical judgment of the investigator, at high risk to develop osteonecrosis of the jaw, including poor oral hygiene, scheduled invasive dental procedures, high doses of bisphosphonates and/or chemotherapy to treat malignancy.
[21] Patients with history of atypical subtrochanteric or diaphyseal femoral fractures, according to the diagnostic criteria of the American Society

Study & Design

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