The Comparison of the Efficacy and Safety of Arzoxifene versus Raloxifene in Postmenopausal Women with Osteoporosis. - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001987-22-IT
• Date of registration: 05/12/2006
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company Limited
• Public title: The Comparison of the Efficacy and Safety of Arzoxifene versus Raloxifene in Postmenopausal Women with Osteoporosis. - ND
• Scientific title: The Comparison of the Efficacy and Safety of Arzoxifene versus Raloxifene in Postmenopausal Women with Osteoporosis. - ND
• Date of first enrolment: 09/11/2006
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001987-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1 are ambulatory, 50 to 75 years of age, inclusive. All women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits 2 had their last natural menstrual period at least 2 years before beginning the study 3 are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study 4 have at least two L1 to L4 lumbar vertebrae that are evaluable via DXA 5 have locally read femoral neck or lumbar spine T-score 61603;-2.5 Table GJAR.1 6 have a follicle stimulating hormone FSH 61502;30 IU/L or 61502;30 mIU/mL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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:
7 have known current metabolic bone disorders other than low bone mass,such as hyperparathyroidism,renal osteodystrophy,or osteomalacia 8 have known,suspected,or history of carcinoma of the breast or estrogen-dependent neoplasia e.g.endometrial carcinoma or any ovarian appearance suspicious for malignancy on screening TVU;be disease free and in remission from all other cancers for 5 or more years,except for excised superficial lesions,such as basal cell carcinoma or squamous cell carcinoma of the skin 9 have demonstrated or suspected allergy to raloxifene or arzoxifene or other components of these study medications 10 have unexplained or abnormal vaginal bleeding within 6 months prior to V1 or between V1 and V2 11 are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy 12 have a history of or suggestion on ultrasound or pelvic examination of a pre-existing gynecologic abnormality that would require further gynecologic treatment e.g.ovarian cysts,large fibroids,undiagnosed adnexal masses 13 have Papanicolaou s tests PAP tests showing malignant or premalignant findings.If the subject has a documented PAP test within 6 months prior to entering the study,and the report demonstrated normal or inflammatory changes only,and this PAP test report is obtained for source documentation,the subject does not need to have the V1 PAP test performed.Abnormal PAP tests must be followed to a benign diagnosis prior to V2 14 for subjects with a uterus, have a screening TVU total bilayer endometrial thickness measurement 5.0 mm,including intracavitary endometrial fluid 15 have any evidence of recent within last 2 years follicular activity consistent with ovulation 16 have active or any past history of thromboembolic events e.g.deep vein-thrombosis,pulmonary embolism,or retinal vein thrombosis 17 have active or any past history of atrial fibrillation 18 have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past 19 have acute or chronic liver disease defined as alanine aminotransaminase ALT 100 U/L,gamma-glutamyl transferase GGT 400 U/L,or late stage cirrhosis without transaminase elevation 20 have impaired kidney function serum creatinine 177 mol/L or 2.0 mg/dL 21 have vit D deficiency,defined as serum 25-hydroxyvitamin D 15 ng/mL or 37.4 nmol/L. If nutritional vit D deficiency is suspected e.g.no malabsorption ,one retest will be allowed.This retest should be performed within 1 week after completing 30 days of calcium and vit D supplementation 22 have any known,severe,or untreated malabsorption syndromes 23 have endocrine disorders requiring pharmacologic therapy except for type II diabetes and hypothyroidism.Subjects on a stable dose of thyroid replacement therapy during the 6 months preceding randomization V2 who are clinically euthyroid in the opinion of the investigator may enroll in the trial 24 consume an excess of alcohol or abuse drugs,in the opinion of the investigator 25 represent an unacceptable medical or psychiatric risk for treatment with an investigational drug,in the opinion of the investigator 26 have active or any history of seizure disorder 27 have breast implants 28 have received treatment with any of the medications listed in Table GJAR.2,according to the listed Conditions for Exclusion,in each case 29 have received treatment within the last 30 days with a drug,not including study drug,that has not received regulatory

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Prevention and treatment of osteoporosis.
MedDRA version: 6.1 Level: PT Classification code 10031285

Intervention(s)

Product Name: Arzoxifene HCl
Product Code: LY353381
Pharmaceutical Form: Tablet
CAS Number: 182133-27-3
Current Sponsor code: LY353381
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: EVISTA*14CPR RIV 60MG

Pharmaceutical Form: Tablet
INN or Proposed INN: Raloxifene
CAS Number: 82640-04-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: EVISTA*14CPR RIV 60MG

Pharmaceutical Form: Tablet
INN or Proposed INN: Raloxifene
CAS Number: 82640-04-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Posterior-anterior lumbar spine BMD measurement.

Secondary Objective: To compare the effect of treatment with orally administered arzoxifene 20 mg/day versus orally administered raloxifene 60 mg/day on the following data in postmenopausal women with osteoporosis BMD at the femoral neck and total hip, as measured by 6- and 12-month percent change from baseline biochemical markers of bone metabolism, as measured by serum CTX and PINP at baseline, 3, 6, and 12 months coagulation parameters, as measured by Protein C, Protein S, and Antithrombin III at baseline, 3, 6, and 12 months breast density, as assessed from bilateral mammograms performed at screening and 12 months incidence of spontaneous vaginal bleeding, as measured by subject query at each visit overall safety.

Main Objective: The primary objective of this study is to compare the effect of orally administered 20 mg arzoxifene daily versus orally administered 60 mg raloxifene daily on 12-month percent change from baseline in lumbar spine BMD in postmenopausal women with osteoporosis, as assessed by dual energy x-ray absorptiometry DXA .

Secondary ID(s)

2006-001987-22-ES

H4Z-MC-GJAR