Trial · NCT02195895
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
NCT02195895, Phase 2, Completed, Northwestern University; results first posted 2018-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide. Trials, record NCT02195895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
- NCT number
- NCT02195895
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Interventions
- Alendronate, Calcium, Vitamin D
- First posted
- 2014-07-21
- Last updated
- 2023-03-30
- Results first posted
- 2018-09-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BMD of Total Hip by DXA | 12 months | The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. |
| Secondary | C-terminal Telopeptide (CTX) | 12 months | The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown. |
| Secondary | BMD by DXA at the Lumbar Spine | 12 months | The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. |
| Secondary | Amino-terminal Propeptide of Type 1 Collagen (P1NP) | 12 months | The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone. |
| Secondary | Bone-specific Alkaline Phosphatase (BSAP) | 12 months | The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BMD of Total Hip by DXA | 12 months | Percent change | MEAN | |
| SECONDARY | C-terminal Telopeptide (CTX) | 12 months | Percent change | MEAN | |
| SECONDARY | BMD by DXA at the Lumbar Spine | 12 months | Percent change | MEAN | |
| SECONDARY | Amino-terminal Propeptide of Type 1 Collagen (P1NP) | 12 months | Percent change | MEAN | |
| SECONDARY | Bone-specific Alkaline Phosphatase (BSAP) | 12 months | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BMD of Total Hip by DXA | Alendronate, Calcium, Vitamin D | 1.32 | 95% Confidence Interval -1.1 to 3.75 | Percent change | |
| C-terminal Telopeptide (CTX) | Alendronate, Calcium, Vitamin D | -61.8 | 95% Confidence Interval -99.8 to -23.7 | Percent change | |
| BMD by DXA at the Lumbar Spine | Alendronate, Calcium, Vitamin D | 2.54 | 95% Confidence Interval 0.17 to 4.90 | Percent change | |
| Amino-terminal Propeptide of Type 1 Collagen (P1NP) | Alendronate, Calcium, Vitamin D | -51.5 | 95% Confidence Interval -93.8 to -9.27 | Percent change | |
| Bone-specific Alkaline Phosphatase (BSAP) | Alendronate, Calcium, Vitamin D | -15.5 | 95% Confidence Interval -50.6 to 19.5 | Percent change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alendronate, Calcium, Vitamin D | 17 | |
| Overall Study | COMPLETED | Alendronate, Calcium, Vitamin D | 17 | |
| Overall Study | NOT COMPLETED | Alendronate, Calcium, Vitamin D | 0 |
Source ClinicalTrials.gov
Adverse events36
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 | Abdominal pain | Gastrointestinal disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Abscess (perineal) | Skin and subcutaneous tissue disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Bacteremia | Blood and lymphatic system disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Blister | Skin and subcutaneous tissue disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Blood clot | Blood and lymphatic system disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Cold | Infections and infestations | Alendronate, Calcium, Vitamin D | 3 | 17 | 4 |
| other | Constipation | Gastrointestinal disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Cyst | Skin and subcutaneous tissue disorders | Alendronate, Calcium, Vitamin D | 2 | 17 | 2 |
| other | Decrease sensation | Nervous system disorders | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
| other | Dizziness | Injury, poisoning and procedural complications | Alendronate, Calcium, Vitamin D | 1 | 17 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alendronate, Calcium, Vitamin D | 0 | 17 |
| Total, other adverse events | Alendronate, Calcium, Vitamin D | 13 | 17 |
| Total, serious adverse events | Alendronate, Calcium, Vitamin D | 4 | 17 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT02195895
GET https://conductscience.org/api/trials/v1/NCT02195895/events?page=2