A Study of Arzoxifene to Treat Korean Women With Osteoporosis

NCT00767299 | Completed Phase 2

• 2 other identifiers: 12185H4Z-MC-GJAV
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses

  6 months

Secondary Outcomes (4)

• Incidence of spontaneous vaginal bleeding.

  6 months

• Total hip BMD

  6 months

• Biochemical marker of bone metabolism (serum CTX and PINP)

  3 and to 6 months

• Overall safety of arzoxifene administration in Korean postmenopausal women

  6 months

Study Arms (2)

1

EXPERIMENTAL

Drug: arzoxifene

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

arzoxifene DRUG

20 mg, QD, PO,24 weeks

Also known as: LY353381

1

Placebo DRUG

QD, PO, 24 weeks

2

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Bucheon-si, 420-767, South Korea

Location

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.

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

LY 353381

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

KR (2)