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

L

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

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

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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