Clinical trial NCT00767299: A Study of Arzoxifene to Treat Korean Women With Osteoporosis
Official title: Effects of Arzoxifene on Bone Mineral Density in Korean Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 91
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is for Korean women who are postmenopausal and also suffer from osteoporosis.

The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene.

All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.


Eligibility criteria: Inclusion Criteria:

* Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture.
* Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed osteoporosis (Inclusion Criterion \[1\]), 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.
* Had their last natural menstrual period at least 2 years before beginning the study.
* Are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
* Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening.
* Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal to -2.5

Exclusion Criteria:

* Have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia.
* Have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. For other cancers, 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.
* Have demonstrated or suspected allergy to raloxifene or arzoxifene
* Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or between Visit 1 and Visit 2.
* Are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy.
* 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) or of baseline endometrial thickness of \>5 mm.
* Have Papanicolaou's tests showing malignant or premalignant findings.
* Have active or any past history of thromboembolic events
* Have active or any past history of atrial fibrillation.
* Have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past.
* 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 elevations.
* Have impaired kidney function (serum creatinine \>177 micromol/L or \>2.0 mg/dL).
* Have vitamin D deficiency prior to enrollment (Visit 2; 25-hydroxyvitamin D less than10 ng/mL or less than 24.9 nmol/L).
* Have any known, severe, or untreated malabsorption syndromes.
* Have endocrine disorders requiring pharmacologic therapy except for type II diabetes and hypothyroidism. Patients on a stable dose of thyroid replacement therapy during the 6 months preceding randomization (Visit 2) who are clinically euthyroid in the opinion of the investigator may enroll in the trial.
* Consume an excess of alcohol or abuse drugs
* Represent an unacceptable medical or psychiatric risk for treatment with an investigational drug
* Have active or any history of seizure disorder.

Primary outcomes:
measure: Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of spontaneous vaginal bleeding.
timeFrame: 6 months
measure: Total hip BMD
timeFrame: 6 months
measure: Biochemical marker of bone metabolism (serum CTX and PINP)
timeFrame: 3 and to 6 months
measure: Overall safety of arzoxifene administration in Korean postmenopausal women
timeFrame: 6 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, 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.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, 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.
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: