Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00259298

First received: November 28, 2005

Last updated: July 14, 2010

Last verified: July 2010

History of Changes

Results First Received: July 14, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteoporosis
Intervention:	Drug: teriparatide

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Participant Flow: Overall Study

	Teriparatide
STARTED	12
Received at Least 1 Dose of Study Drug	10
COMPLETED	9
NOT COMPLETED	3
Withdrawal by Subject	1
Physician Decision	2

Baseline Characteristics

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Reporting Groups

	Description
Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Baseline Measures

	Teriparatide
Number of Participants [units: participants]	12
Age [units: years] Mean ± Standard Deviation	67.17 ± 7.64
Gender [units: participants]
Female	12
Male	0
Race/Ethnicity, Customized [units: participants]
Caucasian	12
Region of Enrollment [units: participants]
United Kingdom	12
Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate ^[1] [units: participants]
no increase	10
possible increase	0
definite increase	0
not assessed	2
Body Mass Index (BMI) ^[2] [units: kg/m2] Mean ± Standard Deviation	24.56 ± 5.16
Height [units: centimeter] Mean ± Standard Deviation	161.25 ± 6.88
Qualitative Visual Score of Focal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) ^[3] [units: units on scale] Mean ± Standard Deviation	0.7 ± 0.48
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) ^[4] [units: milliliter/minute] Median ( Inter-Quartile Range )
whole skeleton	38.30 ( 33.00 to 40.90 )
skull	3.07 ( 2.43 to 3.74 )
mandible	0.17 ( 0.13 to 0.24 )
spine	6.32 ( 4.88 to 7.00 )
pelvis	5.92 ( 5.78 to 6.77 )
upper extremities	3.70 ( 3.41 to 5.15 )
lower extremities	9.12 ( 7.82 to 9.86 )
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) ^[5] [units: percentage of uptake] Median ( Inter-Quartile Range )
whole skeleton	29.4 ( 27.40 to 31.70 )
skull	2.59 ( 1.96 to 2.95 )
mandible	0.14 ( 0.12 to 0.19 )
spine	4.85 ( 3.87 to 5.68 )
pelvis	4.57 ( 4.06 to 5.28 )
upper extremities	2.98 ( 2.29 to 3.81 )
lower extremities	7.09 ( 6.27 to 8.46 )
Weight [units: kilogram] Mean ± Standard Deviation	63.80 ± 13.56
Years post menopause [units: years] Mean ± Standard Deviation	21.84 ± 7.65

[1]	Presented are data only for participants who received a bone scan at baseline. Initial bone scans for each participant were evaluated by a radiologist for an increase in diffuse uptake in the whole skeleton compared to expected values in a healthy population. Subjective visual assessment categorized results into no increase, possible increase, and definite increase.
[2]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[3]	Changes in focal uptake (localized, defined areas of uptake) in the whole skeleton were visually scored. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.
[4]	Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.
[5]	Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.

Outcome Measures

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1. Primary:

Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months [ Time Frame: baseline, 18 months ]

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2. Secondary:

Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities [ Time Frame: Baseline, 3 months, 18 months, 24 months ]

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3. Secondary:

Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities [ Time Frame: Baseline, 3 months, 18 months, 24 months ]

Show Outcome Measure 3

4. Secondary:

Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton [ Time Frame: Baseline, 3 months, 18 months, 24 months ]

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5. Secondary:

Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton [ Time Frame: baseline, 3 months, 18 months, 24 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Other Adverse Events

	Teriparatide
Total, other (not including serious) adverse events
# participants affected / at risk	12/12
Cardiac disorders
Arrhythmia ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	3
Palpitations ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Tachycardia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Ear and labyrinth disorders
Ear disorder ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Eustachian tube obstruction ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Tinnitus ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Vertigo ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Eye disorders
Blepharitis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Cataract ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Chorioretinal disorder ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Optic atrophy ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Vision blurred ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Gastrointestinal disorders
Abdominal discomfort ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Abdominal distension ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Constipation ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Diarrhoea ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Dyspepsia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Gastrooesophageal reflux disease ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	3
Haemorrhoids ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Hiatus hernia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Inguinal hernia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Irritable bowel syndrome ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Lip disorder ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Nausea ^{† 1}
# participants affected / at risk	3/12 (25.00%)
# events	4
General disorders
Chest pain ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Cyst ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Fatigue ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Feeling hot ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Injection site erythema ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Injection site haematoma ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	3
Injection site irritation ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Non-cardiac chest pain ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Pain ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Infections and infestations
Eye infection ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Herpes zoster ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Influenza ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	3
Kidney infection ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Nasopharyngitis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Sinusitis ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Upper respiratory tract infection ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Injury, poisoning and procedural complications
Contusion ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Fall ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Femoral neck fracture ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Fibula fracture ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Fracture ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Fractured coccyx ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Thoracic vertebral fracture ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Investigations
Blood pressure increased ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Cardiac murmur ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Weight increased ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Metabolism and nutrition disorders
Anorexia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Hypercholesterolaemia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Musculoskeletal and connective tissue disorders
Arthralgia ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Back pain ^{† 1}
# participants affected / at risk	3/12 (25.00%)
# events	3
Bone pain ^{† 1}
# participants affected / at risk	3/12 (25.00%)
# events	3
Bursitis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Exostosis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Facet joint syndrome ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Intervertebral disc space narrowing ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Myalgia ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Neck pain ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Osteitis deformans ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Osteoarthritis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Soft tissue disorder ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Spinal osteoarthritis ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	4
Spondylolisthesis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Extensor plantar response ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Headache ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	3
Lethargy ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Migraine ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Nerve compression ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Paraesthesia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Somnolence ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2
Syncope ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Transient ischaemic attack ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	2
Psychiatric disorders
Anxiety ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Depression ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Renal and urinary disorders
Micturition urgency ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Renal cyst ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Respiratory disorder ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Skin and subcutaneous tissue disorders
Hyperhidrosis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Vascular disorders
Aortic stenosis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
# events	1
Hypertension ^{† 1}
# participants affected / at risk	2/12 (16.67%)
# events	2

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12.0

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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.

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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Moore AE, Blake GM, Taylor KA, Rana AE, Wong M, Chen P, Fogelman I. Assessment of regional changes in skeletal metabolism following 3 and 18 months of teriparatide treatment. J Bone Miner Res. 2010 May;25(5):960-7.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00259298 History of Changes
Other Study ID Numbers:	9917, B3D-US-GHCV
Study First Received:	November 28, 2005
Results First Received:	July 14, 2010
Last Updated:	July 14, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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