Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

This study has been completed.

Sponsor:

Information provided by:

Radius Health, Inc.

ClinicalTrials.gov Identifier:

NCT00542425

First received: October 10, 2007

Last updated: June 30, 2010

Last verified: June 2010

History of Changes

Results First Received: June 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Osteoporosis
Interventions:	Drug: teriparatide Drug: Placebo Drug: BA058 20 µg Drug: BA058 40 µg Drug: BA058 80 µg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for the study started in the US, in January 2007. For the initial 24-week treatment period, patients were randomized to study treatment at 30 study centers in the US, Argentina, India and the UK . Eleven of the 30 study centers treated patients in the 24-week treatment extension period in the US, Argentina, and India.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After eligibility was established, patients entered a 4-week Pretreatment Period during which they received daily Calcium and Vitamin D supplements, were trained in self-injection with the pen devices, and were assessed for additional evaluations at the end of the Pretreatment Period. Patients who remained eligible were randomized on Day 1.

Reporting Groups

	Description
Placebo	No text entered.
BA058 20 µg	No text entered.
BA058 40 µg	No text entered.
BA058 80 µg	No text entered.
Teriparatide	No text entered.

Participant Flow for 2 periods

Period 1: Initial 24 Weeks

	Placebo	BA058 20 µg	BA058 40 µg	BA058 80 µg	Teriparatide
STARTED	46	43	43	45	45
COMPLETED	42	33	36	34	39
NOT COMPLETED	4	10	7	11	6
Administrative reasons	0	0	1	1	0
Adverse Event	0	1	1	3	2
Inability to complete procedures	0	3	2	1	2
Lost to Follow-up	2	2	1	0	0
Non-compliance	0	0	0	1	1
Protocol Violation	0	0	0	1	0
Refusal of treatment	2	2	1	4	1
Other	0	2	1	0	0

Period 2: Extended 24 Weeks of Treatment

	Placebo	BA058 20 µg	BA058 40 µg	BA058 80 µg	Teriparatide
STARTED	11 ^[1]	13 ^[1]	10 ^[1]	7 ^[1]	14 ^[1]
COMPLETED	10	11	8	6	13
NOT COMPLETED	1	2	2	1	1
Adverse Event	0	0	1	1	0
Protocol Violation	0	0	1	0	0
Refusal of treatment	0	1	0	0	0
Other	1	1	0	0	1

[1]	Not all patients were eligible for extension study, often due to the regulatory approval timeline.

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
BA058 20 µg	No text entered.
BA058 40 µg	No text entered.
BA058 80 µg	No text entered.
Teriparatide	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	BA058 20 µg	BA058 40 µg	BA058 80 µg	Teriparatide	Total
Number of Participants [units: participants]	46	43	43	45	45	222
Age [units: years] Mean ± Standard Deviation	65 ± 7.11	66.3 ± 6.96	64.5 ± 7.35	64.8 ± 7.21	64.5 ± 7.48	65 ± 7.19
Gender [units: participants]
Female	46	43	43	45	45	222
Male	0	0	0	0	0	0

Outcome Measures

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1. Primary:

Change in Marker of Bone Metabolism, PINP [ Time Frame: 6 months ]

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2. Primary:

Change in Bone Mineral Density, Total Spine. [ Time Frame: 6 months ]

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3. Secondary:

Change in Bone Mineral Density, Femoral Neck. [ Time Frame: 6 months ]

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4. Secondary:

Change in Bone Mineral Density, Total Hip. [ Time Frame: 6 months ]

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Measure Type	Secondary
Measure Title	Change in Bone Mineral Density, Total Hip.
Measure Description	Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.

Reporting Groups

	Description
Placebo	No text entered.
BA058 20 µg	No text entered.
BA058 40 µg	No text entered.
BA058 80 µg	No text entered.
Teriparatide	No text entered.

Measured Values

	Placebo	BA058 20 µg	BA058 40 µg	BA058 80 µg	Teriparatide
Number of Participants Analyzed [units: participants]	41	31	37	35	38
Change in Bone Mineral Density, Total Hip. [units: Percent change from baseline] Mean ± Standard Deviation	0.39 ± 3.053	1.43 ± 2.639	1.97 ± 3.699	2.60 ± 3.488	0.45 ± 3.925

No statistical analysis provided for Change in Bone Mineral Density, Total Hip.

5. Secondary:

Change in Bone Mineral Density, Total Spine. [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

The PI/Institution may publish/present results of the Study provided that the Publication is reviewed by the Sponsor for Confidential Information at least 60 days prior to submission. If the Publication contains patent-related information, the submission shall be delayed for 90 days.

The Institution/PI will not publish until after the data from the multi-center study is published in a combined paper as long as it is completed within 18 months from the date of study completion.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Program Director
Organization: Radius Health, Inc.
phone: (617) 551-4700
e-mail: info@radiuspharm.com

No publications provided

Responsible Party:	Program Director, Radius Health, Inc.
ClinicalTrials.gov Identifier:	NCT00542425 History of Changes
Other Study ID Numbers:	BA058-05-002
Study First Received:	October 10, 2007
Results First Received:	June 30, 2010
Last Updated:	June 30, 2010
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica India: Ministry of Health

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