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A Study for Patients With Osteoporosis

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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)

364 participants in 2 patient groups

A
Experimental group
Treatment:
Drug: Teriparatide
B
Active Comparator group
Treatment:
Drug: Salmon Calcitonin

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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