Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation (JADE)

Ligand Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: lasofoxifene; Drug: Placebo; Drug: Lasofoxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143273

A2181037

Details and patient eligibility

About

To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.

Enrollment: 497 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postmenopausal Asian women with osteoporosis defined by low BMD

Exclusion criteria

• Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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497 participants in 4 patient groups, including a placebo group

Lasofoxifene Dose 1

Experimental group

Description:

0.05 mg

Treatment:

Drug: lasofoxifene

Lasofoxifene Dose 2

Experimental group

Description:

0.25 mg

Treatment:

Drug: Lasofoxifene

Drug: Lasofoxifene

Lasofoxifene Dose 3

Experimental group

Description:

0.5 mg

Treatment:

Drug: Lasofoxifene

Drug: Lasofoxifene

Placebo

Placebo Comparator group

Description:

0 mg

Treatment:

Drug: Placebo