A Study for Patients With Osteoporosis

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Teriparatide; Drug: Salmon Calcitonin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414973

B3D-MC-GHDG

10591

Details and patient eligibility

About

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

Enrollment: 364 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Teriparatide

B

Active Comparator group

Treatment:

Drug: Salmon Calcitonin