Calcium Supplementation in Postmenopausal Women

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis

In brief

This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.

Key facts

Study ID

NCT00172172

Run by

Shire

People needed

374

Starts

2004-01-10

Expected to finish

2005-03-11

Last updated by the study team

2021-05-25

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who are capable of understanding and giving written, voluntary informed consent before the clinical study screening visit
• Women with the ability to self-administer a daily injection or having a designee who will give the injections
• Women who are postmenopausal with at least one year since their last menstruation. If a subject's menopausal status at screening is in question, because of history or because the subject had a hysterectomy without oophorectomy, a follicle-stimulating hormone (FSH) level >40 mIU/mL will satisfy the definition of postmenopausal status.
• Women 45-54 years of age with the following T-score and/or vertebral fracture
• T-score >=3.0 standard deviations (SD) below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip Or
• T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip with a prevalent vertebral fracture verified by the central imaging organization before the subject is enrolled into the study
• Women >=55 years of age with the following T-score and/or vertebral fracture:
• o T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip Or
• T-score >=2.0 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip with a vertebral fracture verified by the central imaging organization before the subject is enrolled into the study
• The following types of vertebral fractures should not be considered for subject enrollment into this study:
• Pathological fractures due to malignant disease or infection
• Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass

You may not qualify if…

• A. Vertebral Deformity (assessed as described in Appendix 2 of the protocol, are sufficient for exclusion):
• · Vertebral deformities
• Patient has 5 or more vertebral (thoracic and lumbar) fractures
• Patient has 2 or more lumbar vertebral deformities (L1 to L4)
• B. DXA Imaging:
• · Inability to have a DXA scan performed, e.g.:
• A history of a lumbar laminectomy which interferes with the DXA measurement of the lumbar vertebrae
• The presence of pedicle screws
• The patient cannot lay flat on her back for the required time to provide accurate imaging
• Patient is not able to have an A/P lumbar vertebral DXA performed
• Patient has a history of vertebroplasty
• Any other excessive degenerative disease which interferes with the DXA measurement of the lumbar vertebrae or hip
• C. History of or Concurrent Illness:
• Disorders of Immunity
• HIV
• Significant* immunological disorders
• Endocrine system
• Any history of hyper- or hypoparathyroidism
• Cushing's disease
• Hyperthyroidism (within 12 months)
• Significant* endocrine disorders
• Gastrointestinal system
• Significant* gastrointestinal disorders
• Kidney and collecting system
• Clinically significant* history of nephrolithiasis or urolithiasis

Where it is running

• 'Boling Clinical Trials — Rancho Cucamonga, California, United States
• 'Radiant Research - Lake Worth — Lake Worth, Florida, United States
• Odyssey Research/Bone Density of North Idaho — Coeur d'Alene, Idaho, United States
• 'The University of Chicago — Chicago, Illinois, United States
• 'University Hospital & Outpatient Center — Indianapolis, Indiana, United States
• 'Bethesda Health Research Center — Bethesda, Maryland, United States
• 'Michigan Bone & Mineral Clinic — Detroit, Michigan, United States
• Odyssey Research — North Platte, Nebraska, United States
• Creighton University School of Medicine — Omaha, Nebraska, United States
• 'New Mexico Clinical Research and Osteoporosis Center — Albuquerque, New Mexico, United States
• 'Odyssey Research Services — Bismarck, North Dakota, United States
• Michael J. Lillestol — Fargo, North Dakota, United States
• 'Odyssey Research Services — Minot, North Dakota, United States
• 'Radiant Research — Wyomissing, Pennsylvania, United States
• Odyssey Research/Avera United Clinic — Aberdeen, South Dakota, United States
• 'Brown Clinic — Watertown, South Dakota, United States
• 'Diabetes Center of the Southwest — Midland, Texas, United States
• 'IDIM — Buenos Aires, BUE, Argentina
• 'Centro de Osteopatias Medicas — Capital Federal, CBA, Argentina
• 'Hospital Clinical del Parque — Chihuahua City, CHIH, Mexico
• 'Hospital Angeles de las Lomas — Huixquilucan, EMEX, Mexico
• 'Hospital Aranda de la Parra — León, Guanajuato, Mexico
• 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca — Guadalajara, Jalisco, Mexico
• 'Hospital Civil de Belem — Guadalajara, Jalisco, Mexico
• 'Medica Monraz — Guadalajara, Jalisco, Mexico

Full record on ClinicalTrials.gov

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