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The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.
Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risedronate | Active Comparator | 35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group) |
|
| Nutritional supplement | Active Comparator | Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group) |
|
| Calcium and vitamin D3 | Active Comparator | An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate | Drug | The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Baseline, 6 months and 12 months |
| Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margareta Hedström, MD, PhD | Karolinska Institutet | Study Director |
| Maria Sääf, MD, PhD | Karolinska Institutet | Study Director |
| Lena Flodin, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Geriatric Medicine R94, Karolinska University Hospital | Stockholm | SE-141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26572609 | Derived | Flodin L, Cederholm T, Saaf M, Samnegard E, Ekstrom W, Al-Ani AN, Hedstrom M. Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study. BMC Geriatr. 2015 Nov 17;15:149. doi: 10.1186/s12877-015-0144-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group B, Bisphosphonates | Patients allocated to intervention B received 35 mg risedronate once weekly for 12 months and 1,000 mg calcium and 800 IU vitamin D3 daily. |
| FG001 | Group BN/N, Bisphosphonates Along With Nutritional Supplementation | Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein. |
| FG002 | Group C, Control | Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group B, Bisphosphonate | Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. |
| BG001 | Group BN/N, Bisphosphonates Along With Nutritional Supplementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline, 6 months and 12 months |
|
Adverse event data were collected 1 year for every patient included.
Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B, Bisphosphonate | Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation/diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lena Flodin | Department of Geriatric Medicine, Karolinska University Hospital, Stockholm, Sweden | Mobile: 0701910300 | lena.flodin@sll.se |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| D019587 | Dietary Supplements |
| D004164 | Diphosphonates |
| D002118 | Calcium |
| D002762 | Cholecalciferol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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|
| Nutritional supplement | Other | The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months. |
|
|
| Calcium and vitamin D3 | Dietary Supplement | The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months. |
|
|
| Baseline, 6 and 12 months |
| Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). | Baseline, 6 and 12 months |
Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein. |
| BG002 | C, Control | Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Patients who were admitted to one of the four university hospitals in Stockholm, Sweden during 2005-2009, with the diagnosis of femoral neck or trochanteric fracture. | Number | participants |
|
| BN/N, Bisphosphonate Along With Nutritional Supplementation |
Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily). |
| OG002 | C, Control | The patients were randomized to receive calcium and vitamin D3 alone and served as controls. |
|
|
|
| Primary | Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. | 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. | Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline, 6 months and 12 months |
|
|
|
|
| Secondary | Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 6 and 12 months |
|
|
|
|
| Secondary | Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. | 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). | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 6 and 12 months |
|
|
|
| 1 |
| 28 |
| 0 |
| 28 |
| 2 |
| 28 |
| EG001 | BN/N, Bisphosphonate Along With Nutritional Supplementation | Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily). | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | C, Control | The patients were randomized to receive calcium and vitamin D3 alone and served as controls. | 0 | 25 | 0 | 25 | 3 | 25 |
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| D007869 |
| Leg Injuries |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| Male |
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| follow-up at 12 months |
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