Trial · NCT01705587

Fracture (FX) Improvement With Teriparatide: FiX-IT Study

NCT01705587, Phase 4, Completed, Susan L. Greenspan; results first posted 2017-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fracture (FX) Improvement With Teriparatide: FiX-IT Study. Trials, record NCT01705587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01705587

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fracture (FX) Improvement With Teriparatide: FiX-IT Study
NCT number: NCT01705587
Status: Completed
Phases: Phase 4
Enrollment: 13 participants, actual
Lead sponsor: Susan L. Greenspan
Conditions: Osteoporosis, Atypical Femoral Fracture
Interventions: teriparatide
First posted: 2012-10-12
Last updated: 2017-12-12
Results first posted: 2017-12-12

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Radiologic Evidence of Bone Healing	6, 12 months of treatment	The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
Primary	Radiologic Evidence of Healing	at 10 weeks for immediate teriparatide group	Number of participants with persistence of alignment as determined by a radiologist.
Secondary	Radiologic Healing	at 2, 6, 24, and 48 weeks
Secondary	Increased Bone Density	at 6 and 12 months	Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
Secondary	Quality of Life Improvements	at 12 months	Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
Secondary	Difference in Biochemical Markers of Bone Turnover	intervals over 12-18 months depending on treatment group	upfront therapy group compared to delayed therapy group and no therapy group

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Radiologic Evidence of Bone Healing	6, 12 months of treatment		units on a scale	MEAN
PRIMARY	Radiologic Evidence of Healing	at 10 weeks for immediate teriparatide group	Based on orthopedic surgeons' assessment, x-rays were not deemed necessary in over 30% of patients at week 10. Results presented are for those who had x-rays at 10 weeks to assess persistence of alignment for safety purposes.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Radiologic Healing	at 2, 6, 24, and 48 weeks	Data not collected at 2 and 6 weeks. Twenty-Four week (6 months) data is presented in 6 month outcomes, and 48 week (12 months) data as 12 month outcomes (See primary outcomes section above).
SECONDARY	Increased Bone Density	at 6 and 12 months		percentage change in BMD	MEAN
SECONDARY	Quality of Life Improvements	at 12 months		units on a scale	MEAN
SECONDARY	Difference in Biochemical Markers of Bone Turnover	intervals over 12-18 months depending on treatment group	Funding unavailable for sample analysis.

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Radiologic Evidence of Bone Healing	Immediate Teriparatide	6 mo	12.6	Standard Error 0.6	units on a scale
Radiologic Evidence of Bone Healing	Delayed Teriparatide	6 mo	11.2	Standard Error 1.3	units on a scale
Radiologic Evidence of Bone Healing	Immediate Teriparatide	12 mo	15.4	Standard Error 0.4	units on a scale
Radiologic Evidence of Bone Healing	Delayed Teriparatide	12 mo	13.2	Standard Error 1.2	units on a scale
Radiologic Evidence of Healing	Immediate Teriparatide		5		Participants
Radiologic Evidence of Healing	Delayed Teriparatide		4		Participants
Increased Bone Density	Immediate Teriparatide	Spine-PA (6 months)	2.1	Standard Error 1.5	percentage change in BMD
Increased Bone Density	Delayed Teriparatide	Spine-PA (6 months)	-0.6	Standard Error 1.3	percentage change in BMD
Increased Bone Density	Immediate Teriparatide	Spine-PA (12 months)	2.8	Standard Error 2.0	percentage change in BMD
Increased Bone Density	Delayed Teriparatide	Spine-PA (12 months)	5.4	Standard Error 2.8	percentage change in BMD

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Immediate Teriparatide	7
Overall Study	STARTED	Delayed Teriparatide	6
Overall Study	COMPLETED	Immediate Teriparatide	7
Overall Study	COMPLETED	Delayed Teriparatide	5
Overall Study	NOT COMPLETED	Immediate Teriparatide	0
Overall Study	NOT COMPLETED	Delayed Teriparatide	1

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fall	Musculoskeletal and connective tissue disorders	Immediate Teriparatide	1	7	1
other	Fall	Musculoskeletal and connective tissue disorders	Delayed Teriparatide	0	6	0
other	aphasia	Nervous system disorders	Immediate Teriparatide	1	7	1
other	aphasia	Nervous system disorders	Delayed Teriparatide	0	6	0
other	myringotomy	Ear and labyrinth disorders	Immediate Teriparatide	1	7	1
other	myringotomy	Ear and labyrinth disorders	Delayed Teriparatide	0	6	0
other	arthralgias	Musculoskeletal and connective tissue disorders	Immediate Teriparatide	1	7	1
other	arthralgias	Musculoskeletal and connective tissue disorders	Delayed Teriparatide	0	6	0
other	pneumonia	Infections and infestations	Immediate Teriparatide	1	7	1
other	pneumonia	Infections and infestations	Delayed Teriparatide	0	6	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Immediate Teriparatide	0	7
Total, all-cause mortality	Delayed Teriparatide	0	6
Total, other adverse events	Immediate Teriparatide	5	7
Total, other adverse events	Delayed Teriparatide	5	6
Total, serious adverse events	Immediate Teriparatide	3	7
Total, serious adverse events	Delayed Teriparatide	2	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Immediate Teriparatide vs Delayed Teriparatide: Radiologic Evidence of Healing	Trial comparisons
Immediate Teriparatide vs Delayed Teriparatide: deaths from any cause	Trial comparisons
Immediate Teriparatide vs Delayed Teriparatide: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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