NCT00172107

Brief Summary

A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1995

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 1995

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 1997

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

May 13, 2021

Conditions

Osteoporosis

Keywords

Post-menopausalOsteoporosisParathyroid HormonePTHALX1-11

Outcome Measures

Primary Outcomes (1)

  • Efficacy was assessed as percent change from baseline in BMD, BMC, and BMA at the lumbar spine, total hip, femoral neck and whole body (excluding the head) using DXA.

    12 months of treatment

Secondary Outcomes (1)

  • Secondary efficacy evaluations were also performed at Month 3, 6, and 12: Percent change from baseline in lumbar spine BMC and BMA; Percent change from baseline in total hip and femoral neck BMD, BMC and BMA

    12 months

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo drug injectable subcutaneously

Drug: placebo

2

EXPERIMENTAL

50 mcg PTH(1-84)

Drug: ALX1-11 50 mcg

3

EXPERIMENTAL

75mcg PTH(1-84)

Drug: ALX1-11 75mcg

4

EXPERIMENTAL

100 mcg PTH(1-84)

Drug: ALX1-11

Interventions

ALX1-11 50 mcgDRUG

PTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen

Also known as: PREOS
2
placeboDRUG

placebo powder for subcutaneous injection

1
ALX1-11 75mcgDRUG

PTH(1-84)75 mcg for subcutaneous injection

Also known as: PREOS
3
ALX1-11DRUG

PTH (1-84) 100mcg for subcutaneous injection into thigh or abdomen

Also known as: PREOS
4

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women aged 50-75 years at Visit 1 (at least 5 years post cessation of menses, or FSH\>20 IU/L, serum estradiol \<110 pmol/L)
  • Vertebral bone mineral density at least 2.5 S.D. below the mean of young normals. Patients must have at least 2 measurable contiguous vertebral bodies in the lumbar region, L1-L4.
  • Ability to self administer injections
  • Ability and willingness to give informed consent

You may not qualify if:

  • Evidence of 5 or more vertebral fractures
  • Evidence of 2 or more vertebral fractures in the region L1-L4
  • Presence of significant cardiac disease as determined by history, physical examination and laboratory screens e.g. cardiac dysrhythmias.
  • Presence of significant hepatic, renal, pulmonary, gastrointestinal, hematological, endocrine, immunologic, neurological or psychiatric disease as determined by history, physical examination and laboratory screens. Specifically excluded are diseases known to contribute to osteoporosis: hyperparathyroidism, hyperthyroidism, glucocorticoid excess, hyper or hypocalcemia, Paget's disease, osteogenesis imperfecta, osteomalacia and severe scoliosis.
  • Evidence of lumbar fusions, osteophytes or excessive degenerative disease which precludes reasonable DXA measurement.
  • History or presence of cancer within the previous 5 years except for superficial basal cell and squamous cell carcinomas of the skin.
  • Treatment with any of the following therapies:
  • Any form of Estrogen within previous 6 months
  • Prior use of Etidronate for more that 2 treatment cycles (2weeks/cycle) and/or any use within prior 6 months
  • Any other bisphosphonate
  • Parathyroid Hormone use within 6 months
  • Fluoride (\>10 mg/day) within 12 months
  • Any form of Calcitonin within previous 4 months
  • Thyroid hormone within previous 4 months unless TSH levels found to remain within normal range
  • Other therapies known to influence bone metabolism\* within previous 4 months
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pivotal Research

Peoria, Arizona, 85381, United States

Location

Loma Linda Osteoporosis Research Clinic

Loma Linda, California, 92354, United States

Location

Steven Harris

Mill Valley, California, 94941, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Paul Miller

Lakewood, Colorado, 80227, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Radiant Research, Stuart

Stuart, Florida, 34996, United States

Location

Maine Center for Osteoporosis Research and Education of St. Joseph's Hospital

Bangor, Maine, 04401, United States

Location

'Bethesda Health Research Center

Bethesda, Maryland, 20817, United States

Location

Helen Hayes Hospital

West Haverstraw, New York, 10993, United States

Location

Oregon Osteoporosis Center

Portland, Oregon, 97213, United States

Location

Simona Scumpia

Austin, Texas, 78758, United States

Location

Radiant Research, Dallas

Dallas, Texas, 75235, United States

Location

'Diabetes & Glandular Disease Research Associates, P.A.

San Antonio, Texas, 78229, United States

Location

Northwest Lipid Research Center

Seattle, Washington, 98104, United States

Location

Heritage Medical Research Clinic

Calgary, Alberta, T2N 4N1, Canada

Location

Osteoporosis Research Center

Vancouver, British Columbia, V5Z 2N6, Canada

Location

Capital Health Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

St. Joseph's Health Center

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

May 18, 1995

Primary Completion

March 24, 1997

Study Completion

March 24, 1997

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

US(15)CA(4)