The Forteo Alendronate Comparator Trial (FACT)

Lilly

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Dietary Supplement: Vitamin D; Drug: Placebo-SC; Dietary Supplement: Calcium; Drug: Alendronate; Drug: Teriparatide; Drug: Placebo-Oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02416271

4943

B3D-MC-GHBM (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.

Enrollment: 203 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with osteoporosis.
• Ambulatory, 5 years or more past menopause.
• BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
• Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

Exclusion criteria

• Prior treatment with PTH or a PTH analogue.
• Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
• History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
• History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
• Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
• Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.
• Abnormal uncorrected thyroid function.
• Liver disease or clinical jaundice.
• Alcohol or other drug abuse.
• Poor medical or psychiatric risk for treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 2 patient groups

Teriparatide

Experimental group

Description:

20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Calcium

Drug: Teriparatide

Drug: Placebo-Oral

Alendronate

Active Comparator group

Description:

10 milligrams/day alendronate orally plus SC injection placebo for 18 months.

Treatment:

Dietary Supplement: Vitamin D

Drug: Alendronate

Dietary Supplement: Calcium

Drug: Placebo-SC