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Completed

NCT Number: NCT02416271

The Forteo Alendronate Comparator Trial

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Recife, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teriparatide

Drug

Administered SC

Other names: LY333334, Forteo, Forsteo

Alendronate

Drug

Administered orally

Calcium

Dietary Supplement

Administered orally

Vitamin D

Dietary Supplement

Administered orally

Placebo-Oral

Drug

Administered orally

Placebo-SC

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline to 18 Months in Lumbar Spine BMD

    Time frame: Baseline, 18 Months

Secondary outcomes

  1. Percent Change from Baseline in Lumbar Spine BMD

    Time frame: Baseline, 3 Months, 6 Months, 12 Months

  2. Percent Change from Baseline in Total Hip and Femoral Neck BMD

    Time frame: Baseline, 12 Months, 18 Months

  3. Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine

    Time frame: Baseline, 6 Months, 18 Months

  4. Percent Change from Baseline in Cortical BMD at the Femoral Neck

    Time frame: Baseline, 6 Months, 18 Months

  5. Percent Change from Baseline in Trabecular BMD at the Femoral Neck

    Time frame: Baseline, 6 Months, 18 Months

  6. Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)

    Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months

  7. Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)

    Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months

  8. Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)

    Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months

  9. Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)

    Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months

  10. Percentage of Participants with Nonvertebral Fractures

    Time frame: 18 Months

  11. Percentage of Participants with Clinical Fractures

    Time frame: 18 Months

  12. Change from Baseline on the Back Pain Questionnaire

    Time frame: Baseline, 3 Months, 6 Months, 18 Months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis

Acronym: FACT

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Apr 14, 2015
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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