A Study for Patients With Osteoporosis

Eli Lilly and Company364 enrolled

Overview

The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

364

Conditions

Osteoporosis

Interventions

TeriparatideDRUG

Subcutaneous, 20 micrograms/day, 24 weeks

Salmon CalcitoninDRUG

Intranasal, 200 International Units (IU)/day, 24 weeks

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of osteoporosis * No other severe disabling conditions * Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5 * Ambulatory * Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years) Exclusion Criteria: * History of a disease that affects bone metabolism * History of treatment with any drug that may significantly affect bone metabolism * History or presence of liver disease * History or presence of kidney disease * History of excessive alcohol drinking or drug abuse

Locations (5)

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.

Beijing, China

Chengdu, China

Outcomes

Primary Outcomes

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women

Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Time frame: Baseline to 24 weeks

Secondary Outcomes

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women

Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Time frame: Baseline to 24 weeks

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women

Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.

Time frame: Baseline to 12 weeks and 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men

Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Time frame: Baseline to 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men

Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Time frame: Baseline to 24 weeks

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men

Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.

Data from ClinicalTrials.gov

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