Calcium Supplementation in Postmenopausal Women

NCT00172172 | Completed Phase 3

• 1 other identifier: CL1-11-008
• Study Type: interventional
• Target: 374
• Locations: 3 countries
• Sites: 27

Brief Summary

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.

Conditions

Osteoporosis

Keywords

Post-menopausal; Osteoporosis; Parathyroid Hormone; PTH; ALX1-11

Outcome Measures

Primary Outcomes (2)

• Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation).

  6 months

• Primary efficacy variable is the percentage change from baseline of lumbar vertebral BMDmeasured by DXA.

  6 months

Secondary Outcomes (16)

• BMC,

  6 months

• vBMD,

  6 months

• the incidence of clinical fractures,

  6 months

• height,

  6 months

• biochemical markers of bone turnover for subjects treated with ALX1-11 and receiving no calcium versus those receiving ALX1-11 with calcium supplementation.

  6 months

Study Arms (3)

1

EXPERIMENTAL

PTH 100 mcg and 700 mg calcium

Drug: PTH/Calcium

2

EXPERIMENTAL

PTH 100 mcg and placebo

Drug: PTH/placebo

3

PLACEBO COMPARATOR

Placebo and 700 mg calcium

Drug: placebo

Interventions

PTH/Calcium DRUG

PTH(1-84) subcutaneous injection and calcium 700 mg oral

Also known as: PREOS

1

PTH/placebo DRUG

PTH (1-84) injected subcutaneously and placebo provided orally

Also known as: PREOS

2

placebo DRUG

Placebo injected subcutaneously and 700 mg calcium orally

3

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• · 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

Sponsors & Collaborators

• Shire: lead

Study Sites (27)

'Boling Clinical Trials

Rancho Cucamonga, California, 91730, United States

Location

'Radiant Research - Lake Worth

Lake Worth, Florida, 33461, United States

Location

Odyssey Research/Bone Density of North Idaho

Coeur d'Alene, Idaho, 83814, United States

Location

'The University of Chicago

Chicago, Illinois, 60637, United States

Location

'University Hospital & Outpatient Center

Indianapolis, Indiana, 46202, United States

Location

'Bethesda Health Research Center

Bethesda, Maryland, 20817, United States

Location

'Michigan Bone & Mineral Clinic

Detroit, Michigan, 48236, United States

Location

Odyssey Research

North Platte, Nebraska, 69101, United States

Location

Creighton University School of Medicine

Omaha, Nebraska, 68131, United States

Location

'New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

'Odyssey Research Services

Bismarck, North Dakota, 58501, United States

Location

Michael J. Lillestol

Fargo, North Dakota, 58103, United States

Location

'Odyssey Research Services

Minot, North Dakota, 58701, United States

Location

'Radiant Research

Wyomissing, Pennsylvania, 19610, United States

Location

Odyssey Research/Avera United Clinic

Aberdeen, South Dakota, 57401, United States

Location

'Brown Clinic

Watertown, South Dakota, 57201, United States

Location

'Diabetes Center of the Southwest

Midland, Texas, 79705, United States

Location

'IDIM

Buenos Aires, BUE, C1012AAR, Argentina

Location

'Centro de Osteopatias Medicas

Capital Federal, CBA, C1114AAI, Argentina

Location

'Hospital Clinical del Parque

Chihuahua City, CHIH, 31020, Mexico

Location

'Hospital Angeles de las Lomas

Huixquilucan, EMEX, 52763, Mexico

Location

'Hospital Aranda de la Parra

León, Guanajuato, 37000, Mexico

Location

'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Guadalajara, Jalisco, 44340, Mexico

Location

'Hospital Civil de Belem

Guadalajara, Jalisco, 44650, Mexico

Location

'Medica Monraz

Guadalajara, Jalisco, 44670, Mexico

Location

'Instituto Mexicano de Investigacion Clinica

Mexico City, Mexico City, 06700, Mexico

Location

'Hospital Universitario de Monterrey

Monterrey Nuevo Leon, 64040, Mexico

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: January 10, 2004
• Primary Completion: March 11, 2005
• Study Completion: March 11, 2005
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

US (17); AR (2); ME (8)