NCT01950169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

September 1, 2014

Enrollment Period

4.4 years

First QC Date

September 23, 2013

Results QC Date

November 8, 2020

Last Update Submit

March 20, 2021

Conditions

Hip Fracture

Keywords

Hip fractureNutritional supplementBisphosphonatesBone mineral densityBody composition

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.

    Baseline, 6 and 12 months

  • Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.

    Baseline, 6 and 12 months

Study Arms (3)

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)

Drug: RisedronateDietary Supplement: Calcium and vitamin D3

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)

Drug: RisedronateOther: Nutritional supplementDietary Supplement: Calcium and vitamin D3

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)

Dietary Supplement: Calcium and vitamin D3

Interventions

RisedronateDRUG

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.

Also known as: Bisphosphonate Group (B)
Nutritional supplementRisedronate
Nutritional supplementOTHER

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.

Also known as: Bisphosphonate and nutritional supplemented Group (BN)
Nutritional supplement
Calcium and vitamin D3DIETARY_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.

Also known as: Control Group (C)
Calcium and vitamin D3Nutritional supplementRisedronate

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Recent fracture of the femoral neck or trochanter
  • Without severe cognitive impairment
  • Ambulant before fracture
  • BMI ≤ 28

You may not qualify if:

  • Abnormal parameters regarding liver i.e. S-Alanine aminotransferase (S-ALAT) and S-Aspartate aminotransferase (S-ASAT) ≥ twice as normal
  • Abnormal parameters regarding kidney i.e. S-Creatinine \> 130 µg/L
  • Primary hyperparathyroidism, osteogenesis imperfecta, Paget´s disease
  • Myeloma
  • Lactose intolerance
  • Dysphagia
  • Esophagitis
  • Gastric ulcer
  • Malignancy
  • Diabetes with nephropathy or retinopathy
  • Active iritis or uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatric Medicine R94, Karolinska University Hospital

Stockholm, SE-141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 26572609DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Risedronic AcidDietary SupplementsDiphosphonatesCalciumCholecalciferolControl Groups

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Dr. Lena Flodin
Organization
Department of Geriatric Medicine, Karolinska University Hospital, Stockholm, Sweden
lena.flodin@sll.se
Mobile: 0701910300

Study Officials

  • Margareta Hedström, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

  • Maria Sääf, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

  • Lena Flodin, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

December 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 14, 2021

Results First Posted

April 14, 2021

Record last verified: 2014-09

Locations

SE(1)