Trial · NCT01950169
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
NCT01950169, Not applicable, Completed, Karolinska Institutet; results first posted 2021-04-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture. Trials, record NCT01950169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950169
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
- NCT number
- NCT01950169
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 79 participants, actual
- Lead sponsor
- Karolinska Institutet
- Conditions
- Hip Fracture
- Interventions
- Risedronate, Nutritional supplement, Calcium and vitamin D3
- First posted
- 2013-09-25
- Last updated
- 2021-04-14
- Results first posted
- 2021-04-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 months and 12 months | Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered. |
| Primary | Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 months and 12 months | Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered. |
| Secondary | Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 and 12 months | Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m\^2). |
| Secondary | Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 and 12 months | Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m\^2). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 months and 12 months | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. | g/cm^2 | MEAN |
| PRIMARY | Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 months and 12 months | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. | g/cm^2 | MEAN |
| SECONDARY | Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 and 12 months | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design. | kg/m^2 | MEAN |
| SECONDARY | Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. | Baseline, 6 and 12 months | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design. | kg/m^2 | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | B, Bisphosphonate | follow up at 6 months | -0.008 | Standard Deviation 0.037 | g/cm^2 |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | BN/N, Bisphosphonate Along With Nutritional Supplementation | follow up at 6 months | 0.005 | Standard Deviation 0.026 | g/cm^2 |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | C, Control | follow up at 6 months | -0.017 | Standard Deviation 0.026 | g/cm^2 |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | B, Bisphosphonate | follow up at 12 months | -0.012 | Standard Deviation 0.042 | g/cm^2 |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | BN/N, Bisphosphonate Along With Nutritional Supplementation | follow up at 12 months | -0.004 | Standard Deviation 0.025 | g/cm^2 |
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | C, Control | follow up at 12 months | -0.018 | Standard Deviation 0.032 | g/cm^2 |
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | B, Bisphosphonate | follow-up at 6 months | -0.005 | Standard Deviation 0.018 | g/cm^2 |
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | BN/N, Bisphosphonate Along With Nutritional Supplementation | follow-up at 6 months | -0.006 | Standard Deviation 0.018 | g/cm^2 |
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | C, Control | follow-up at 6 months | -0.012 | Standard Deviation 0.019 | g/cm^2 |
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | B, Bisphosphonate | follow-up at 12 months | -0.003 | Standard Deviation 0.022 | g/cm^2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group B, Bisphosphonates | 28 | |
| Overall Study | STARTED | Group BN/N, Bisphosphonates Along With Nutritional Supplementation | 26 | |
| Overall Study | STARTED | Group C, Control | 25 | |
| Overall Study | COMPLETED | Group B, Bisphosphonates | 25 | |
| Overall Study | COMPLETED | Group BN/N, Bisphosphonates Along With Nutritional Supplementation | 18 | |
| Overall Study | COMPLETED | Group C, Control | 24 | |
| Overall Study | NOT COMPLETED | Group B, Bisphosphonates | 3 | |
| Overall Study | NOT COMPLETED | Group BN/N, Bisphosphonates Along With Nutritional Supplementation | 8 | |
| Overall Study | NOT COMPLETED | Group C, Control | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Constipation/diarrhea | Gastrointestinal disorders | B, Bisphosphonate | 2 | 28 | |
| other | Constipation/diarrhea | Gastrointestinal disorders | BN/N, Bisphosphonate Along With Nutritional Supplementation | 0 | 26 | |
| other | Constipation/diarrhea | Gastrointestinal disorders | C, Control | 3 | 25 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | B, Bisphosphonate | 1 | 28 |
| Total, all-cause mortality | BN/N, Bisphosphonate Along With Nutritional Supplementation | 0 | 26 |
| Total, all-cause mortality | C, Control | 0 | 25 |
| Total, other adverse events | B, Bisphosphonate | 2 | 28 |
| Total, other adverse events | BN/N, Bisphosphonate Along With Nutritional Supplementation | 0 | 26 |
| Total, other adverse events | C, Control | 3 | 25 |
| Total, serious adverse events | B, Bisphosphonate | 0 | 28 |
| Total, serious adverse events | BN/N, Bisphosphonate Along With Nutritional Supplementation | 0 | 26 |
| Total, serious adverse events | C, Control | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26572609 | DERIVED |
Source PubMed
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/NCT01950169
GET https://conductscience.org/api/trials/v1/NCT01950169/results?page=2