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Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

NCT ID: NCT00365456

Last Updated: 2012-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-08-31

Brief Summary

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The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Detailed Description

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Conditions

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Osteoporosis

Keywords

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Lumbar Spine Bone Mineral Density (BMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTH (1-84)

Group Type EXPERIMENTAL

Parathyroid Hormone (PTH)

Intervention Type DRUG

Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.

Risedronate

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

Orally once weekly as one 35 mg tablet.

Interventions

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Parathyroid Hormone (PTH)

Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.

Intervention Type DRUG

Risedronate

Orally once weekly as one 35 mg tablet.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
2. Is the subject above 50 years old?
3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
4. Does the subject have primary osteoporosis with a lumbar spine T score \< -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
5. Does the subject have a life expectancy of \>3 years?
6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nycomed Clinical Trial Operations

Role: STUDY_CHAIR

Headquaters

Locations

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Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2005-000730-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1132-3246

Identifier Type: REGISTRY

Identifier Source: secondary_id

FP-001-IM

Identifier Type: -

Identifier Source: org_study_id